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Review on Simultaneous Equation Method (Vierodt’s Method) 联立方程法(Vierodt法)述评
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00026
Amit J. Vyas, Shalini Anilkumar Jha, A. Patel, AI Patel, S. R. Shah, D. Sheth
The article consists of brief review on Simultaneous equation method (Vierodt’s method). This method is applicable for estimation of those drugs whose spectra overlap properly I.e. If a sample contains two absorbing drug each of which absorbing at λmax of the other, it is possible to determine both drugs by technique of simultaneous equation method. This article consists of the list of various combined dosage form and food sample analyzed by Vierodt’s method with its wavelength, linearity range and choice of solvents. This method permits simple, rapid and direct determination of combined dosage form without prior separation and therefore can be used in routine analysis. Quantitative estimation is necessary before introduction of any drug into the market because if concentration is more in formulation it can lead to toxicity problem or if concentration is found less, then formulation will not be effective in prescribed dose.
本文对联立方程法(Vierodt法)作了简要回顾。该方法适用于光谱有适当重叠的药物的估计,即如果样品中含有两种吸收药物,每一种药物在λmax处吸收另一种药物,则可以用联立方程法技术确定两种药物。本文介绍了维罗特法分析的各种组合剂型和食品样品的波长、线性范围和溶剂的选择。该方法简便、快速、直接地测定复方剂型,无需预先分离,可用于常规分析。在任何药物进入市场之前,定量评估是必要的,因为如果配方中的浓度过高,可能会导致毒性问题,或者如果浓度过低,那么配方在规定剂量下就不会有效。
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引用次数: 3
A Brief Review on Dissolution Method Development 溶出法研究进展综述
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00023
Ashok B. Patel, Avadhi R. Bundheliya, Rushali V. Zala, Amit J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth
Dissolution testing is a critical methodology; widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium. The BCS has been a predictive tool for assess the prospective effects of formulation on the human, drug oral bioavailability. When used in combination with in vitro dissolution tests, the BCS can maintain the prediction of in vivo product performance and the development. Filtration is critical in drug dissolution testing as filtration stops the dissolution process and allows for accurate quantitation through separation of dissolved and un-dissolved components. The objective of this investigation was to determine if other sinker shapes will influence the rate, extent, or variability of dissolution. Dissolution test is required to study the drug release from the dosage form and its in vivo performance. Dissolution test is used to asses the lot-to-lot quality of drug product. development and validation of dissolution procedure(s) and to provide practical approaches for determining specificity, linearity, range, accuracy, precision, LOD, LOQ and robustness of methods.
溶出度测试是一种关键的方法;广泛应用于新药品的开发。该试验以其最简单的形式包括将制剂置于含有合适溶解介质的溶解装置中。BCS已成为评估制剂对人、药物口服生物利用度的前瞻性影响的预测工具。当与体外溶出度试验结合使用时,BCS可以保持对体内产品性能和发展的预测。过滤在药物溶出度测试中是至关重要的,因为过滤停止了溶出过程,并允许通过分离溶解和未溶解成分进行准确定量。本研究的目的是确定其他下沉物的形状是否会影响溶解的速率、程度或变异性。通过溶出度试验来研究药物在剂型中的释放和体内性能。溶出度试验用于评定药品批间质量。开发和验证溶出程序,并提供确定方法的特异性,线性,范围,准确度,精密度,LOD, LOQ和鲁棒性的实用方法。
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引用次数: 1
Stability Indicating UV-Spectrophotometric Method Development and its Validation for the Determination of Imatinib Mesylate in Bulk and Formulation 稳定性指示紫外分光光度法测定甲磺酸伊马替尼原料药和制剂的方法建立及验证
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00015
R. Sri, Soundarya Soundarya, K. B. Sri, S. M
A Simple and precise UV-spectroscopic method was developed for the determination of Imatinib Mesylate in its bulk and formulation. The developed method has been validated for various parameters like specificity, accuracy, linearity, robustness according to USP general chapter<1225> and ICH Q2R1 guidelines. Pure solution of Imatinib Mesylate was scanned in the whole range of UV region where it has shown the maximum absorbance at 258nm. The RSD values for method precision and intermediate precision were found to be well within the acceptance criteria and the series of dilutions were found to be linear (2-12ug/ml) where r2= 0.999 was the regression value. Limit of detection (0.2925μg/ml) and Limit of quantification (0.8977μg/ml) of IMT were established. Further, the drug has been subjected to various stress conditions, and percent degraded was reported. Drug solutions have shown stability on the benchtop for up to 8 hours and 72 hours when the solutions were refrigerated.
建立了甲磺酸伊马替尼原料药和制剂中甲磺酸伊马替尼含量的紫外光谱测定方法。根据USP通章和ICH Q2R1指南,对所开发的方法进行了特异性、准确性、线性、稳健性等各种参数的验证。对甲磺酸伊马替尼纯溶液进行全紫外扫描,在258nm处吸光度最大。方法精密度和中间精密度的RSD值均在可接受标准范围内,稀释度系列呈线性(2 ~ 12ug/ml),回归值r2= 0.999。建立了IMT的检测限(0.2925μg/ml)和定量限(0.8977μg/ml)。此外,该药物已受到各种压力条件,和百分比降解的报道。药物溶液在实验台上的稳定性可达8小时,冷藏后可达72小时。
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引用次数: 2
RP-HPLC method for swift analysis of Lamivudine and Dolutegravir in formulation, stability studies 反相高效液相色谱法快速分析拉米夫定和多替格拉韦的处方、稳定性研究
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00019
D. Mamata, Srinu Naik Sapavatu
New RP-HPLC method have been developed for simultaneous analysis of lamivudine and dolutegravir in pharmaceutical dosage forms and applied to stability studies of drugs. The title analytes were eluted rapidly with phosphate buffer (pH 5.0) and acetonitrile (60:40 v/v) on Std discovery C18 (150 x 4.6 mm, 5 µ) column. The detection was carried out using PDA detector at 260 nm. The solutions were chromatographed at a constant flow rate of 1 mL/min. Lamivudine and Dolutegravir were eluted at 2.37 min and 2.97 min respectively with good resolution. Method was validated as ICH guidelines. The linearity range of lamivudine and dolutegravir were found to be of 18.75 - 112.5 µg/mL and 3.125 - 18.75 µg/mL, respectively. The % RSD values (< 2) in precision studies indicates the reproducibility of method. The percentage recoveries were 100.17 % and 100.36 % respectively for lamivudine and dolutegravir, found to be within the limits. The proposed validated method was fruitfully applied for assay of formulation and stability studies of drugs under various stress conditions.
建立了同时分析拉米夫定和多替格拉韦的反相高效液相色谱方法,并将其应用于药物稳定性研究。用磷酸盐缓冲液(pH 5.0)和乙腈(60:40 v/v)在Std discovery C18 (150 × 4.6 mm, 5µ)柱上快速洗脱标题分析物。用PDA检测器在260 nm处进行检测。以1ml /min的恒定流速对溶液进行色谱。拉米夫定和多路地韦洗脱时间分别为2.37 min和2.97 min,洗脱时间较好。方法按照ICH指南进行验证。拉米夫定和多替重力韦的线性范围分别为18.75 ~ 112.5µg/mL和3.125 ~ 18.75µg/mL。精密度研究的% RSD值< 2表示方法的重复性。拉米夫定和多替重力韦的加样回收率分别为100.17%和100.36%,均在限定范围内。该方法可用于各种应激条件下药物的处方分析和稳定性研究。
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引用次数: 0
Review on Forced Degradation Study of Statins 他汀类药物强制降解研究进展
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00024
Priyanka S. Sutar, Manojkumar K. Munde, Vijaya S. Vichare, Nilesh S. Kulkarni
The degradation of new drug ingredients and drug products in more severe settings than accelerated conditions is referred to as forced degradation research. Forced degradation experiments were carried out to demonstrate the specificity of stability-indicating methodologies, providing insight into degradation pathways and drug degradation products, and assisting in the understanding of degradation product structures., identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies Statins, a type of lipid-lowering medication, are the most commonly prescribed and are an example of an unstable drug. In the presence of high temperatures and humidity, statins are susceptible to hydrolysis. As a result, the review discusses various studies of statin drug forced degradation studies. To describe the drug's intrinsic stability, the terms atorvastatin, Fluvastatin, pitavastatin, ruvastatin, simvastatin, and pravastatin are used. assist the selection of formulations and packaging as well as proper storage conditions.
新药成分和药品在比加速条件更严重的环境下的降解被称为强制降解研究。进行强制降解实验以证明稳定性指示方法的特异性,为降解途径和药物降解产物提供洞察,并协助理解降解产物结构。,识别在药物储存和使用过程中可能自发产生的降解产物,并促进与加速稳定性研究相对应的制造过程和配方的改进。他汀类药物是一种降脂药物,是最常用的处方,也是不稳定药物的一个例子。在高温和高湿环境下,他汀类药物容易水解。因此,本综述讨论了他汀类药物强制降解研究的各种研究。为了描述药物的内在稳定性,使用了术语阿托伐他汀、氟伐他汀、匹伐他汀、鲁伐他汀、辛伐他汀和普伐他汀。协助选择配方和包装以及适当的储存条件。
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引用次数: 0
UV Spectrophotometric Method Development and Validation for Amlodipine Besylate in Bulk and Tablet Dosage Form 苯磺酸氨氯地平散装和片剂的紫外分光光度法研究与验证
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00017
P. Priya, Archana Gahtori
Analytical method development and validation is important in development of pharmaceutical preparations. In present study a spectroscopic method for determination of Amlodipine besylate in pharmaceutical dosage form has been developed and validated. The wavelength maxima of Amlodipine besylate was found to be 360nm. Ethanol was used as a solvent. Amlodipine besylate obeys beers law in the concentration range of 5-40μg/ml. The line equation obtained is y = 0.0136x + 0.001 with correlation coefficient (r2) of 0.998. Interday, intraday variations were studied to determine the precision of the proposed method and was found to be with good precision as the %RSD was less than 2%. The assay of 2 different marketed formulation (A and B) has been performed and the % assay of A and B was found to be 98.3% and 99.2% respectively. The sensitivity of the method was determined by LOD and LOQ was found to be 0.08123µg/ml and 0.2461µg/ml respectively. The method employed the parameters like linearity, accuracy, precision, sensitivity, robustness, ruggedness and all the procedures were as per ICH guidelines.
分析方法的开发和验证是药物制剂开发的重要环节。建立了分光光度法测定药物剂型苯磺酸氨氯地平的方法并进行了验证。苯磺酸氨氯地平的最大波长为360nm。乙醇作为溶剂。苯磺酸氨氯地平在5 ~ 40μg/ml浓度范围内符合比尔斯定律。得到直线方程为y = 0.0136x + 0.001,相关系数(r2)为0.998。研究了日间和日内的变化以确定所提出方法的精度,并发现该方法具有良好的精度,因为%RSD小于2%。对两种不同的市售制剂(A和B)进行了测定,A和B的%测定率分别为98.3%和99.2%。定量限为0.08123µg/ml,定量限为0.2461µg/ml。方法采用线性、准确度、精密度、灵敏度、鲁棒性、坚固性等参数,所有程序均按ICH指南执行。
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引用次数: 1
GC-MS analysis of phytocomponents in the ethylacetate extract of Mesua ferrea Linn. leaves 铁杉乙酸乙酯提取物中植物成分的GC-MS分析。叶子
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00022
Sruthikrishna P.K., S. Shrikumar
Mesua ferrea Linn., commonly called Nagakesara or Ceylon iron wood belongs to the family Calophyllaceae. The present study deals with the Gas Chromatography Mass Spectroscopy analysis of Mesua ferrea, which have different medicinal properties. The aim of this study was to identify the phytocomponents present in the ethylacetate extract of Mesua ferrea by using Shimadzu GC-MS Model number: QP2010S equipped with Column - ELITE-5MS (30 meter length, 0.25 mm ID, and 0.25 µm thicknesses). Fourteen compounds were identified and which includes (-)-.alpha.-copaene, .alpha.-Bergamotene, (+)-valencene, beta-eudesmene, .alpha.-selinene, .beta.-Bisabolene, 2, 4-ditert-butylphenol, delta.-cadinene, neophytadiene, Phytol, .beta.-Resorcylic acid, 5-(3, 7-dimethyl-2, 6-octadienyl)-6-pentyl-, ethyl ester, (E)-, Squalene, nonadecane, tricosane.
墨苏亚铁属植物。铁木,俗称长竹或锡兰,属于铁木科。采用气相色谱-质谱法对具有不同药用特性的铁花进行了分析。本研究采用岛津(Shimadzu)气相色谱-质谱仪(GC-MS),型号:QP2010S,色谱柱- ELITE-5MS(柱长30米,ID 0.25 mm,厚度0.25µm),对铁树叶乙酸乙酯提取物中的植物成分进行鉴定。共鉴定出14种化合物,其中包括(-)- α。-copaene .alpha。-佛手柑烯,(+)-价,-桉木烯,。-selinene度量。-双abolene 2,4 -二叔丁基苯酚-癸二烯,新癸二烯,叶绿醇,--间苯二酸,5-(3,7 -二甲基- 2,6 -辛二烯基)-6-戊基-乙酯,(E)-,角鲨烯,壬烷,三聚糖。
{"title":"GC-MS analysis of phytocomponents in the ethylacetate extract of Mesua ferrea Linn. leaves","authors":"Sruthikrishna P.K., S. Shrikumar","doi":"10.52711/2231-5675.2022.00022","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00022","url":null,"abstract":"Mesua ferrea Linn., commonly called Nagakesara or Ceylon iron wood belongs to the family Calophyllaceae. The present study deals with the Gas Chromatography Mass Spectroscopy analysis of Mesua ferrea, which have different medicinal properties. The aim of this study was to identify the phytocomponents present in the ethylacetate extract of Mesua ferrea by using Shimadzu GC-MS Model number: QP2010S equipped with Column - ELITE-5MS (30 meter length, 0.25 mm ID, and 0.25 µm thicknesses). Fourteen compounds were identified and which includes (-)-.alpha.-copaene, .alpha.-Bergamotene, (+)-valencene, beta-eudesmene, .alpha.-selinene, .beta.-Bisabolene, 2, 4-ditert-butylphenol, delta.-cadinene, neophytadiene, Phytol, .beta.-Resorcylic acid, 5-(3, 7-dimethyl-2, 6-octadienyl)-6-pentyl-, ethyl ester, (E)-, Squalene, nonadecane, tricosane.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"124 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88627396","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}
引用次数: 1
Development and Validation of Rapid RP-HPLC Method for determination of Deferasirox in Bulk and Tablet Dosage Forms 快速反相高效液相色谱法测定去铁霉素原料药和片剂含量的建立与验证
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00013
Santhosh Kumar Ettaboina, Komalatha Nakkala, Nayana Chathalingath
The reverse phase high performance liquid chromatographic method has been developed for the estimation of Deferasirox in bulk and in tablet dosage form. Further optimized HPLC method was validated as per the current ICH guidelines. The experiment was conducted on a Inertsil ODS-3V C18, 150mm length, 4.6mm ID, and 5µm particle size column using the chromatographic separation was done with 60:40 v/v ratio of Acetonitrile and Buffer (0.05% Orthophosphoric Acid) as the mobile phase at a flow rate of 1.5mL min-1, and detection of component was made at 250nm. The HPLC method was accurate, with linearity ranging from 10.8 to 162µg/mL of Deferasirox, the correlation coeffient >0.999. The method was exposed to a high accuracy of more than 97%. The results disclose the successful applicability of the current process for the estimation of Deferasirox from its drug substance and marketed formulation, which can be consciously inferred to assess the other formulation systems. The developed method was validated in terms of linearity, accuracy, precision, LOD, LOQ, robustness & ruggedness. The proposed method can be helpful in Quality control laboratories for the determination of Deferasirox in the pharmaceutical dosage form.
建立了反相高效液相色谱法测定去铁沙星原料药和片剂的含量。进一步优化的HPLC方法按照现行ICH指南进行验证。色谱柱为Inertsil ODS-3V C18,柱长150mm,柱径4.6mm,粒径5µm,以60:40 v/v比的乙腈和缓冲液(0.05%正磷酸)为流动相,流速1.5mL min-1,在250nm处进行组分检测。HPLC法准确度高,在10.8 ~ 162µg/mL范围内呈线性关系,相关系数>0.999。该方法的准确率达到97%以上。结果表明,目前的方法可以成功地适用于从其原料药和已上市的制剂中对去铁呋司进行评估,这可以有意识地推断出评估其他制剂体系的方法。从线性度、准确度、精密度、LOD、LOQ、稳健性和耐用性等方面对该方法进行了验证。本方法可用于质量控制实验室中去铁霉素的含量测定。
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引用次数: 6
Stability Indicating RP-HPLC Method Development and Validation for The Simultaneous Estimation of Flupentixol and Melitracen in API from and Marketed Tablet Dosage form 稳定性指示反相高效液相色谱法同时测定原料药和市售片剂中氟哌替索和美利曲辛含量的方法建立与验证
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00021
S. Beula, T. Reddy, V. M., R. Y.
The present work describes a reverse phase high performance liquid chromatographic method (RP-HPLC) for the simultaneous estimation of Flupentixol and Melitracen in bulk and in tablet dosage form. Chromatographic separation was performed on Hypersil (C18) (250mm x 4.6mm, 5µm) Column, with a mobile phase comprising of a mixture of methanol and Acetonitrile in the ratio of 34:66v/v. The flow rate was 1.0ml/min with detection at 257nm. Retention times of Flupentixol and Melitracen were found to be 1.791min and 3.465min respectively. As per International Conference on Harmonization (ICH) guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, and robustness. Linearity of Flupentixol was found to be in the range of 60-140µg/mL. and that for Melitracen was found to be 30-70µg/mL. The Precision (Repeatability, Intra-day and Inter-day) of the Flupentixol and Melitracen was found to be within the limits. The correlation coefficients were 0.999 and 0.999 for Flupentixol and Melitracen respectively. The mean recoveries obtained for Flupentixol and Melitracen were 100.28% and 99.79%. This demonstrates that the developed method is simple, precise, accurate, reproducible and rapid for simultaneous estimation of these drugs in bulk and in tablet dosage forms.
本文建立了反相高效液相色谱法(RP-HPLC)同时测定氟哌替索和美利曲辛散装和片剂剂型的含量。色谱分离采用Hypersil (C18) (250mm × 4.6mm, 5µm)色谱柱,流动相为甲醇与乙腈的混合物,比例为34:66v/v。流速1.0ml/min,检测波长257nm。氟哌噻索和美利曲辛的保留时间分别为1.791min和3.465min。根据国际协调会议(ICH)指南,对该方法进行了线性,准确度,精密度,定量限,检测限和鲁棒性验证。氟哌噻醇在60 ~ 140µg/mL范围内呈线性关系。美利曲辛为30 ~ 70µg/mL。氟哌噻和美利曲森的精密度(重复性、日内、日间)均在限定范围内。氟哌噻醇和美利曲辛的相关系数分别为0.999和0.999。氟哌噻索和美利曲辛的平均回收率分别为100.28%和99.79%。结果表明,所建立的方法简便、精密度高、准确度高、重现性好、快速,可用于原料药和片剂的同时测定。
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引用次数: 2
Development and Validation of New Analytical Method for Estimation of Anthelmintic in Tablet Dosage Form 片剂剂型中驱虫剂含量新分析方法的建立与验证
Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00018
S. Patharkar, K. Gajbhiye, Nawaz Hakam, AM. Vyawahare
A rapid, sensitive and accurate method for Estimation of Anti- Histamine in Tablet Dosage Form by RP-HPLC. Mobile phase was Methanol: 0.1% Ortho phosphoric acid (80:20% v/v). Flow rate was 0.9 ml/min. The detection Wavelength was 227 nm. The injection volume was 20-µl. The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. Linearity studies for Levamisole was performed (10-60µg/ml). The %RSD for accuracy found to be less than2%. Assay was found to be 99.17 to 101.65 respectively The range of 10-60µg /ml was selected for the linearity of a standard Levamisole. The 80%, 100% and 120% levels of recovery study were selected to perform the recovery study. Linearity studies for Levamisole was performed on (10-60µg /ml).
反相高效液相色谱法快速、灵敏、准确地测定片剂剂型中抗组胺含量。流动相为甲醇:0.1%邻位磷酸(80:20% v/v)。流速0.9 ml/min。检测波长为227 nm。进样量为20µl。该方法的选择性、精密度、线性度和准确度均得到了验证。所有验证参数均在可接受范围内。左旋咪唑(10 ~ 60µg/ml)呈线性关系。准确度的RSD小于2%。左旋咪唑的线性范围为10 ~ 60µg /ml。选取回收率研究的80%、100%和120%水平进行回收率研究。左旋咪唑浓度为(10-60µg /ml)时进行线性研究。
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引用次数: 2
期刊
Asian Journal of Pharmaceutical Analysis
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