Pub Date : 2018-01-01DOI: 10.4172/2153-2435.1000E192
Samanidou Vf
Biopharmaceuticals, such as monoclonal antibodies (mAbs), interferons/cytokines, vaccines etc contribute progressively more to clinical practice. They are complex macromolecules produced from living cells by means of biotechnology, usually produced to treat lifethreatening diseases, such as tumors, autoimmune diseases, diabetes, etc. Compared to traditional drugs, biopharmaceuticals are much larger in size, which ranges from 2,000 to 2,000,000 Daltons, while traditional pharmaceuticals are typically within the range 100-1500 Daltons. Another significant difference between them is the number of active sites (functional groups) in biopharmaceuticals, which is significantly higher usually 10-2000. All these characteristics make their investigation of great analytical challenge. Due to their complexity, biopharmaceuticals require multiple modes of chromatographic separations. Moreover the fact that exact copies of biopharmaceuticals cannot be produced; this results to the production of biosimilars that refer to drugs with similar physicochemical characteristics, as well as efficacy and safety with the originators. The ongoing development in biosimilar manufacturing has led to the demand for complementary analytical methods in order to achieve the efficient comparison with originators. At present there are more than 200 approved biopharmaceuticals in the market and this is predicted to increase. Although monoclonal antibodies are the prevailing biopharmaceuticals, novel drugs like antibody drug conjugates (ADCs) have become of particular oncological interest. These are capable to deliver the chemotherapeutic cytotoxic agent directly to the tumor site antigen. By this approach the risk of damaging healthy tissues is intensely reduced. Thereby they take advantage of the benefits of large molecule specificity with small molecule toxicity [1-5].
{"title":"Two-Dimensional Liquid Chromatography (2D-LC) for Biopharmaceuticals","authors":"Samanidou Vf","doi":"10.4172/2153-2435.1000E192","DOIUrl":"https://doi.org/10.4172/2153-2435.1000E192","url":null,"abstract":"Biopharmaceuticals, such as monoclonal antibodies (mAbs), interferons/cytokines, vaccines etc contribute progressively more to clinical practice. They are complex macromolecules produced from living cells by means of biotechnology, usually produced to treat lifethreatening diseases, such as tumors, autoimmune diseases, diabetes, etc. Compared to traditional drugs, biopharmaceuticals are much larger in size, which ranges from 2,000 to 2,000,000 Daltons, while traditional pharmaceuticals are typically within the range 100-1500 Daltons. Another significant difference between them is the number of active sites (functional groups) in biopharmaceuticals, which is significantly higher usually 10-2000. All these characteristics make their investigation of great analytical challenge. Due to their complexity, biopharmaceuticals require multiple modes of chromatographic separations. Moreover the fact that exact copies of biopharmaceuticals cannot be produced; this results to the production of biosimilars that refer to drugs with similar physicochemical characteristics, as well as efficacy and safety with the originators. The ongoing development in biosimilar manufacturing has led to the demand for complementary analytical methods in order to achieve the efficient comparison with originators. At present there are more than 200 approved biopharmaceuticals in the market and this is predicted to increase. Although monoclonal antibodies are the prevailing biopharmaceuticals, novel drugs like antibody drug conjugates (ADCs) have become of particular oncological interest. These are capable to deliver the chemotherapeutic cytotoxic agent directly to the tumor site antigen. By this approach the risk of damaging healthy tissues is intensely reduced. Thereby they take advantage of the benefits of large molecule specificity with small molecule toxicity [1-5].","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"204 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75718550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/2153-2435.1000601
Aggarwal Nn, Bhat Ki, Jacob Jt
Aim: Development and validation of a stability indicating assay method for Tenofovir Alafenamide Fumarate tablets (25 mg strength) by RP-HPLC.Methodology: An efficient experimental design based on systematic scouting of all key components of the RP‐HPLC method and stress studies were performed. The separations were carried out on a C-18 reversed phase column (Inertsil ODS, 100 x 4.6 mm, 5 μ) using a mobile phase consisting of pH 6.0 ammonium acetate buffer and a solvent mixture (30:70) of ACN and THF in the ratio of 990:10 (Mobile phase A) and 500:500 (Mobile phase B) in a gradient elution mode at a flow rate of 1.50 mL/min and column oven temperature of 45°C. The wavelength of detection was 260 nm. Analytical validation parameters such as selectivity, linearity, accuracy, precision and robustness were evaluated as per ICH Q2 (R1) guidelines.Results: USP plate count and the USP tailing factor for the pure drug peak was found to be 9082 and 0.98 respectively which are well within the acceptance criteria. Forced degradation studies performed revealed that none of the degradants generated interfered with the pure drug peak.Conclusion: The proposed method can hence be used for routine analysis of Tenofovir Alafenamide Fumarate.
{"title":"Stability Indicating Assay Method Development and Validation for Tenofovir Alafenamide Fumarate by RP-HPLC","authors":"Aggarwal Nn, Bhat Ki, Jacob Jt","doi":"10.4172/2153-2435.1000601","DOIUrl":"https://doi.org/10.4172/2153-2435.1000601","url":null,"abstract":"Aim: Development and validation of a stability indicating assay method for Tenofovir Alafenamide Fumarate tablets (25 mg strength) by RP-HPLC.Methodology: An efficient experimental design based on systematic scouting of all key components of the RP‐HPLC method and stress studies were performed. The separations were carried out on a C-18 reversed phase column (Inertsil ODS, 100 x 4.6 mm, 5 μ) using a mobile phase consisting of pH 6.0 ammonium acetate buffer and a solvent mixture (30:70) of ACN and THF in the ratio of 990:10 (Mobile phase A) and 500:500 (Mobile phase B) in a gradient elution mode at a flow rate of 1.50 mL/min and column oven temperature of 45°C. The wavelength of detection was 260 nm. Analytical validation parameters such as selectivity, linearity, accuracy, precision and robustness were evaluated as per ICH Q2 (R1) guidelines.Results: USP plate count and the USP tailing factor for the pure drug peak was found to be 9082 and 0.98 respectively which are well within the acceptance criteria. Forced degradation studies performed revealed that none of the degradants generated interfered with the pure drug peak.Conclusion: The proposed method can hence be used for routine analysis of Tenofovir Alafenamide Fumarate.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"13 5","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91549650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/2153-2435.1000E194
S. Tasleem
The application of honey as internal and external remedies is dates back to the history of medicine itself. In the ancient times, the Greek and Egyptians used unprocessed honey to inhibit microbial infections and in the treatment of wound management [2-4]. The earliest evidence of its application in wound management was a recipe for an ointment inscribed on the 4500 years old fragment of clay tablet. The writing of Smith papyrus (1650 BC) shows that Egyptian applied honey as a component in topical application of wounds 4000 years ago [5,6]. Hippocrates (460-357 BC) used many of the Egyptian prescription, in the treatment of carbuncles, running sores and ulcers of the lips effectively. In 50 A.D, Dioscorides gave the valued status to honey for the treatment of all types rotten and hollow ulcers [7]. Thus there is a long history of its application of cure wide variety of wounds infection at folk level and still used in folk medicine for its beneficial therapeutic and medicinal effects. In 1982 Emarah treated 102 patients of various ophthalmological disorders (keratitis, conjunctivitis and blepharitis) with honey not responding to conventional treatment [8]. Improvement was observed in 85% of the cases and with no any deterioration observed with the other 15% redness of the eye and transient stinging sensation was reported soon after putting honey in the eye, but this is not enough to stop the treatment.
{"title":"Medicinal Effect of Honey","authors":"S. Tasleem","doi":"10.4172/2153-2435.1000E194","DOIUrl":"https://doi.org/10.4172/2153-2435.1000E194","url":null,"abstract":"The application of honey as internal and external remedies is dates back to the history of medicine itself. In the ancient times, the Greek and Egyptians used unprocessed honey to inhibit microbial infections and in the treatment of wound management [2-4]. The earliest evidence of its application in wound management was a recipe for an ointment inscribed on the 4500 years old fragment of clay tablet. The writing of Smith papyrus (1650 BC) shows that Egyptian applied honey as a component in topical application of wounds 4000 years ago [5,6]. Hippocrates (460-357 BC) used many of the Egyptian prescription, in the treatment of carbuncles, running sores and ulcers of the lips effectively. In 50 A.D, Dioscorides gave the valued status to honey for the treatment of all types rotten and hollow ulcers [7]. Thus there is a long history of its application of cure wide variety of wounds infection at folk level and still used in folk medicine for its beneficial therapeutic and medicinal effects. In 1982 Emarah treated 102 patients of various ophthalmological disorders (keratitis, conjunctivitis and blepharitis) with honey not responding to conventional treatment [8]. Improvement was observed in 85% of the cases and with no any deterioration observed with the other 15% redness of the eye and transient stinging sensation was reported soon after putting honey in the eye, but this is not enough to stop the treatment.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"62 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73902219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/2153-2435-C3-038
pImeda Rubashvilip
{"title":"Development and validation of sampling procedures and quantitative determination HPLC methods of active pharmaceutical ingredient alprazolam residues on pharmaceutical technological equipment","authors":"pImeda Rubashvilip","doi":"10.4172/2153-2435-C3-038","DOIUrl":"https://doi.org/10.4172/2153-2435-C3-038","url":null,"abstract":"","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"68 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89325553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/2153-2435.1000600
W. Mohammed, T. Safaa, Abou El-Alamin Mm, Nahla Ns, El-Hashash Ma
Stability indicating Synchronous spectrofluorimetric (SF) method has been proposed and validated for the determination of bimatoprost in presence of its acid, base, and oxidative degradation products by measuring SF at 272 nm using delta lamba (âλ)=30 nm in water. Bimatoprost was subjected to stress conditions of 2 M HCL, 2 M NaoH and 30% H2O2 . The identification of degradation products were done by LC-MS. The pathway of degradation was postulated. The effect of different experimental parameters on the fluorescence of the drug was studied and optimized. The range of linearity was over 25-250 ng/mL, the detection limit of 0.005 ng/ mL, and quantitation limit of 0.018 ng/ mL for bimatoprost. The developed method was validated according to ICH guidelines. The accuracy was checked by applying the proposed method for the determination of the drug and it’s degradant. The mean recoveries percentages were found to be 99.39 ± 1.08. RSD values for precision (repeatability and intermediate) testing was 0.569 and 1.28 respectively. The developed method was applied effectively for analysis of the drug in its ophthalmic formulation. The developed method was statistically compared with the reported method revealing high accuracy with good precision. The suggested method was found to be a green analytical chemistry method; the solvent used is water and hence that method can be suitable for routine analysis of the studied drug without effecting the environment harmfully
本文提出并验证了同步荧光光谱法(SF)在水中使用δ λ ( λ)=30 nm在272 nm处测量SF，用于测定存在其酸、碱和氧化降解产物的bimatoprost。Bimatoprost在2 M HCL, 2 M NaoH和30% H2O2的胁迫条件下进行。采用LC-MS对降解产物进行鉴定。假设了降解的途径。研究并优化了不同实验参数对药物荧光的影响。比马前列素的线性范围在25 ~ 250 ng/mL，检出限为0.005 ng/mL，定量限为0.018 ng/mL。根据ICH指南对该方法进行了验证。将该方法应用于该药物及其降解物的测定，验证了该方法的准确性。平均加样回收率为99.39±1.08。精密度(重复性和中间性)试验的RSD值分别为0.569和1.28。所建立的方法可有效地用于该药眼科配方的分析。与已有的方法进行了统计比较，结果表明该方法准确度高，精密度好。该方法是一种绿色分析化学方法;所使用的溶剂为水，因此该方法适用于所研究药物的常规分析，而不会对环境产生有害影响
{"title":"Utility of Synchronous Spectrofluorimetric Method for Rapid Selective Determination of Bimatoprost: Stress Stability Study and Green Analytical Application","authors":"W. Mohammed, T. Safaa, Abou El-Alamin Mm, Nahla Ns, El-Hashash Ma","doi":"10.4172/2153-2435.1000600","DOIUrl":"https://doi.org/10.4172/2153-2435.1000600","url":null,"abstract":"Stability indicating Synchronous spectrofluorimetric (SF) method has been proposed and validated for the determination of bimatoprost in presence of its acid, base, and oxidative degradation products by measuring SF at 272 nm using delta lamba (âλ)=30 nm in water. Bimatoprost was subjected to stress conditions of 2 M HCL, 2 M NaoH and 30% H2O2 . The identification of degradation products were done by LC-MS. The pathway of degradation was postulated. The effect of different experimental parameters on the fluorescence of the drug was studied and optimized. The range of linearity was over 25-250 ng/mL, the detection limit of 0.005 ng/ mL, and quantitation limit of 0.018 ng/ mL for bimatoprost. The developed method was validated according to ICH guidelines. The accuracy was checked by applying the proposed method for the determination of the drug and it’s degradant. The mean recoveries percentages were found to be 99.39 ± 1.08. RSD values for precision (repeatability and intermediate) testing was 0.569 and 1.28 respectively. The developed method was applied effectively for analysis of the drug in its ophthalmic formulation. The developed method was statistically compared with the reported method revealing high accuracy with good precision. The suggested method was found to be a green analytical chemistry method; the solvent used is water and hence that method can be suitable for routine analysis of the studied drug without effecting the environment harmfully","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"93 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90982672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/2153-2435.1000603
Spadaro A, Lorenti M, Zasa G, Rao M
A specific, sensitive, reliable, low-cost, isocratic, ultra-fast HPLC-DAD for Levofloxacin quantification in rabbit aqueous humor was developed, validated and applied to a pharmacokinetic study, conducted on commercial formulation of Levofloxacin. Separations were obtained on a XB-C18 column (100A, 100 mm × 4.60 mm, 2.6 μm, Phenomenex) with an isocratic mobile phase consisting of 18% acetonitrile and 82% triethylamine 0.5% in water (pH adjusted to 2.5 with H3PO4) at a flow rate of 0.5 ml/min. Detection of levofloxacin was done at 292 nm, and the column temperature was 40°C. The total analysis run-time was 5 min per sample, and no interfering peaks from aqueous humor were detected. Method was found to be selective, linear (R2=0.99984), accurate (intra-day recovery, 98.24%-100.04%) and precise (RSD, ≤ 5.50%). Pharmacokinetic parameters in rabbit aqueous humors were calculated by PKSolver add in program and are in agreement with literature data. The outlined method can be efficiently applied for monitoring levofloxacin in aqueous humor in pharmacokinetics studies.
建立了一种特异、灵敏、可靠、低成本、等密度、超快速的HPLC-DAD定量兔房水中左氧氟沙星的方法，并对其进行了验证，并应用于左氧氟沙星商业配方的药代动力学研究。色谱柱为XB-C18 (100A, 100 mm × 4.60 mm, 2.6 μm, Phenomenex)，流动相为18%乙腈和82%三乙胺，流动相为0.5%水(以H3PO4调节pH至2.5)，流速为0.5 ml/min。左氧氟沙星的检测波长为292 nm，柱温为40℃。每个样品的总分析运行时间为5分钟，未检测到房水的干扰峰。结果表明，该方法具有良好的选择性、线性(R2=0.99984)、准确度(日内回收率为98.24% ~ 100.04%)和精密度(RSD≤5.50%)。采用PKSolver软件对兔体液的药动学参数进行了计算，结果与文献相符。该方法可有效地用于房水中左氧氟沙星的药代动力学研究。
{"title":"Development and Validation of a New Ultra-fast HPLC Method for Quantification of Levofloxacin in Rabbit Aqueous Humour: Application to a Pharmacokinetic Study","authors":"Spadaro A, Lorenti M, Zasa G, Rao M","doi":"10.4172/2153-2435.1000603","DOIUrl":"https://doi.org/10.4172/2153-2435.1000603","url":null,"abstract":"A specific, sensitive, reliable, low-cost, isocratic, ultra-fast HPLC-DAD for Levofloxacin quantification in rabbit aqueous humor was developed, validated and applied to a pharmacokinetic study, conducted on commercial formulation of Levofloxacin. Separations were obtained on a XB-C18 column (100A, 100 mm × 4.60 mm, 2.6 μm, Phenomenex) with an isocratic mobile phase consisting of 18% acetonitrile and 82% triethylamine 0.5% in water (pH adjusted to 2.5 with H3PO4) at a flow rate of 0.5 ml/min. Detection of levofloxacin was done at 292 nm, and the column temperature was 40°C. The total analysis run-time was 5 min per sample, and no interfering peaks from aqueous humor were detected. Method was found to be selective, linear (R2=0.99984), accurate (intra-day recovery, 98.24%-100.04%) and precise (RSD, ≤ 5.50%). Pharmacokinetic parameters in rabbit aqueous humors were calculated by PKSolver add in program and are in agreement with literature data. The outlined method can be efficiently applied for monitoring levofloxacin in aqueous humor in pharmacokinetics studies.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"83 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86867022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/2153-2435-C3-040
A. Younas
{"title":"Diagnostic accuracy of cannabinoid testing by liquid chromatography-tandem mass spectrometry in human hair","authors":"A. Younas","doi":"10.4172/2153-2435-C3-040","DOIUrl":"https://doi.org/10.4172/2153-2435-C3-040","url":null,"abstract":"","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"60 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91164504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/2153-2435.1000598
Hamoudi Nm
Every year many patients are affected by adverse drug events that result from the complication of drug therapy. Drug-Drug Interactions (DDIs) are an expected subtype of adverse drug events. Most potential DDIs are preventable, but it remains a significant problem to patients and the health care system. Among the risk factors associated to DDIs include older age, comorbidities, polypharmacy and hospital stay for long time. DDIs are a considerable clinical problem in the hospitalized cardiac patients, cancer patients, hypertensive patients, and patients with immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections. Best management of DDIs involves the assessment of the interaction; decision to prescribe, dispense, or manage the interacting combination; follow-up monitoring and suitable patient counseling. Different studies were performed to detect and avoid DDIs. Different strategies have been introduced to reduce and prevent the risk of DDIs through the improvement of labeling on metabolic profile for new drugs and serious drug-drug and drug -gene combination, determination the effect of new guideline on product labeling changes for elderly patient and patients with polypharmacy. In clinical practice pharmacist can use good information sources; clinicians can use screening software for the detection and management of DDIs; consumers and patients can use decision support systems for potential DDIs and medication reconciliation should be considered by healthcare professionals to reduce medication error.
{"title":"Does Drug-drug Interactions Attain Enough Attention from Health Care Providers?","authors":"Hamoudi Nm","doi":"10.4172/2153-2435.1000598","DOIUrl":"https://doi.org/10.4172/2153-2435.1000598","url":null,"abstract":"Every year many patients are affected by adverse drug events that result from the complication of drug therapy. Drug-Drug Interactions (DDIs) are an expected subtype of adverse drug events. Most potential DDIs are preventable, but it remains a significant problem to patients and the health care system. Among the risk factors associated to DDIs include older age, comorbidities, polypharmacy and hospital stay for long time. DDIs are a considerable clinical problem in the hospitalized cardiac patients, cancer patients, hypertensive patients, and patients with immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections. Best management of DDIs involves the assessment of the interaction; decision to prescribe, dispense, or manage the interacting combination; follow-up monitoring and suitable patient counseling. Different studies were performed to detect and avoid DDIs. Different strategies have been introduced to reduce and prevent the risk of DDIs through the improvement of labeling on metabolic profile for new drugs and serious drug-drug and drug -gene combination, determination the effect of new guideline on product labeling changes for elderly patient and patients with polypharmacy. In clinical practice pharmacist can use good information sources; clinicians can use screening software for the detection and management of DDIs; consumers and patients can use decision support systems for potential DDIs and medication reconciliation should be considered by healthcare professionals to reduce medication error.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"31 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82422471","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/2153-2435.1000592
A. Latif, F. Akbar, Khan Aj, H. Shafi, M. Mazhar
The aim of this study was to develop and validate a simple, robust, reliable and an accurate isocratic reverse phase high-performance liquid chromatography (RP-HPLC) method for quantification of Losartan potassium in solid dosage form using DAD Detector. Elution was carried out with mobile phase comprising of 0.01 M monobasic potassium dihydrogen phosphate buffer (adjusted at pH 3.0 ± 0.05 with ortho-phosphoric acid) and methanol (40: 60), through octadecyl silyl (C18) column (15 cm x 4.6 mm x 5 μl), at flow rate of 1 ml/min. The detection was carried out at 230 nm. The developed method was validated according to International Conference on Harmonization (ICH) guidelines (ICH 2005). The assay was linear in concentration range of 1-3 µgmL-1 with Correlation coefficient of 0.999. The limit of detection was 0.036 µgmL-1 and limit of quantification was 0.110 µg/ml. Similarly, method accuracy was asses by comparing the %RSD of BP method with the %RSD of the method developed which shows RSD for standard method was 1.012% while for developed method it was 1.516% and combined RSD of both two methods was found 1.823% that was as per the precision criteria of accuracy i.e. <2%. The result of intraday study was 0.129% and Intermediate precision among inter day and brand to brand was 0.332%. Moreover, the devised method seems to be linear over broad range of LK concentration (1-3 µgmL-1) with appreciable repeatability and reproducibility (RSD <2.00). The results of present study indicate that the method is efficient, specific, sensitive and suitable to be used for the determination of losartan potassium in solid dosage forms using isocratic mode in comparison to gradient mode used by United States pharmacopoeia (USP 2016).
本研究旨在建立一种简便、可靠、准确的等密度反相高效液相色谱(RP-HPLC)测定固体剂型氯沙坦钾含量的方法。流动相为0.01 M磷酸二氢钾缓冲液(正磷酸调节pH为3.0±0.05)和甲醇(40∶60)，十八烷基硅基(C18)柱(15 cm × 4.6 mm × 5 μl)，流速为1 ml/min。检测波长为230 nm。根据国际协调会议(ICH)指南(ICH 2005)对开发的方法进行了验证。在1 ~ 3µgmL-1浓度范围内呈线性关系，相关系数为0.999。检测限为0.036µg/ml，定量限为0.110µg/ml。同样，通过将BP法的%RSD与开发方法的%RSD进行比较来评估方法的准确性，其中标准方法的RSD为1.012%，开发方法的RSD为1.516%，两种方法的综合RSD为1.823%，符合准确度<2%的精密度标准。日间研究结果为0.129%，日间和品牌间的中间精度为0.332%。此外，所设计的方法在LK浓度(1-3µgmL-1)的宽范围内似乎是线性的，具有明显的重复性和再现性(RSD <2.00)。本研究结果表明，与美国药典(USP) 2016年采用的梯度法相比，本方法具有高效、特异、灵敏的特点，适用于固体剂型氯沙坦钾含量的等密度测定。
{"title":"Development and Validation of Analytical Method for Quantification of Losartan Potassium in Solid Dosage Form","authors":"A. Latif, F. Akbar, Khan Aj, H. Shafi, M. Mazhar","doi":"10.4172/2153-2435.1000592","DOIUrl":"https://doi.org/10.4172/2153-2435.1000592","url":null,"abstract":"The aim of this study was to develop and validate a simple, robust, reliable and an accurate isocratic reverse phase high-performance liquid chromatography (RP-HPLC) method for quantification of Losartan potassium in solid dosage form using DAD Detector. Elution was carried out with mobile phase comprising of 0.01 M monobasic potassium dihydrogen phosphate buffer (adjusted at pH 3.0 ± 0.05 with ortho-phosphoric acid) and methanol (40: 60), through octadecyl silyl (C18) column (15 cm x 4.6 mm x 5 μl), at flow rate of 1 ml/min. The detection was carried out at 230 nm. The developed method was validated according to International Conference on Harmonization (ICH) guidelines (ICH 2005). The assay was linear in concentration range of 1-3 µgmL-1 with Correlation coefficient of 0.999. The limit of detection was 0.036 µgmL-1 and limit of quantification was 0.110 µg/ml. Similarly, method accuracy was asses by comparing the %RSD of BP method with the %RSD of the method developed which shows RSD for standard method was 1.012% while for developed method it was 1.516% and combined RSD of both two methods was found 1.823% that was as per the precision criteria of accuracy i.e. <2%. The result of intraday study was 0.129% and Intermediate precision among inter day and brand to brand was 0.332%. Moreover, the devised method seems to be linear over broad range of LK concentration (1-3 µgmL-1) with appreciable repeatability and reproducibility (RSD <2.00). The results of present study indicate that the method is efficient, specific, sensitive and suitable to be used for the determination of losartan potassium in solid dosage forms using isocratic mode in comparison to gradient mode used by United States pharmacopoeia (USP 2016).","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"25 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81469697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2017-12-29DOI: 10.4172/2153-2435.1000572
M. Saini
In recent years, the dielectric study of amorphous pharmaceuticals has made a considerable effort towards correlating the molecular mobility with their physical and chemical stability. The molecular mobility of amorphous materials is affected by temperature, additives (such as water) and specific interactions (such as Hydrogen bond). Therefore, to understand the physicochemical instability of amorphous materials, nature of their molecular mobility needs to comprehend. In this order, the Dielectric and Calorimetric measurements were performed on a mixture of ibuprofen and 1,4-dioxane. The dielectric spectroscopy reveals two relaxation processes, (designated as αD, and α) in the supercooled region. The spectral shape of αD and α process can be explained satisfactorily throughout the frequency range using Havriliak-Negami (HN) shape function. The αD process is found to be Debye-like (i.e., αHN=0 and βHN=1) in nature and α process kinetically freezes at Tg-onset (DSC) implies that α- process indeed corresponds to the glass transition event. Both processes are found to be non-Arrhenius in nature. In addition, two secondary relaxation processes (designated as βJG and β) are observed and are comparable with the literature. The activation energy of β process indicates that it‟s originating from the fluctuations of the side group larger than -OH group. Also, the calculated fragility index demonstrates that ibuprofen is a fragile glass former.
{"title":"Dielectric Spectroscopy in Ibuprofen-Dioxane Mixture","authors":"M. Saini","doi":"10.4172/2153-2435.1000572","DOIUrl":"https://doi.org/10.4172/2153-2435.1000572","url":null,"abstract":"In recent years, the dielectric study of amorphous pharmaceuticals has made a considerable effort towards correlating the molecular mobility with their physical and chemical stability. The molecular mobility of amorphous materials is affected by temperature, additives (such as water) and specific interactions (such as Hydrogen bond). Therefore, to understand the physicochemical instability of amorphous materials, nature of their molecular mobility needs to comprehend. \u0000In this order, the Dielectric and Calorimetric measurements were performed on a mixture of ibuprofen and 1,4-dioxane. The dielectric spectroscopy reveals two relaxation processes, (designated as αD, and α) in the supercooled region. The spectral shape of αD and α process can be explained satisfactorily throughout the frequency range using Havriliak-Negami (HN) shape function. The αD process is found to be Debye-like (i.e., αHN=0 and βHN=1) in nature and α process kinetically freezes at Tg-onset (DSC) implies that α- process indeed corresponds to the glass transition event. Both processes are found to be non-Arrhenius in nature. In addition, two secondary relaxation processes (designated as βJG and β) are observed and are comparable with the literature. The activation energy of β process indicates that it‟s originating from the fluctuations of the side group larger than -OH group. Also, the calculated fragility index demonstrates that ibuprofen is a fragile glass former.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"21 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2017-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86479837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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