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Stability indicating novel analytical method development by RP-UPLC for the estimation of Gitingensine in bulk 稳定性表明RP-UPLC分析方法的发展是一种新的分析方法
Pub Date : 2022-03-15 DOI: 10.14805/jphchem.2022.art128
Sowmya Panduri, Theja Indireddy, Ramya Kuber Banoth
A new method was proposed using RP-UPLC for the determination of Gitingensine in bulk, which exhibits its power of stability output. Gitingensine is a natural product found in Kibatalia laurifolia belonging to Apocynaceae which is a steroid having the activities such as anti-inflammatory, anti-spasmodic and anti-cancer activity. Cevadine is used as an internal standard for chromatographic analysis. The elution was performed on BEH C18 (2.1 × 50 mm, 1.7 µm) column at 30 °C with a mobile phase distribution Acetonitrile: 0.1% orthophosphoric acid (60: 40) respectively. The flow rate was well- kept at 0.3 mL min-1. Retention times for Gitingensine and Cevadine were found to be 2.005 and 1. 395 min, respectively. The regression equation was found to be linear in the range of 12.5 – 75 µg/mL with a high correlation coefficient (0.999). Recovery of Gitingensine was obtained as 100.04%. Validation was done as claimed by ICH guidelines with respect to accuracy, sensitivity, robustness, and precision studies. From the insignificant variations in the analysis by changing the mobile phase, temperature, and flow rate, the robustness was studied. All the validation parameters were found to be within the specifications. Forced degradation studies revealed that when the influence of acid, alkali, peroxide, thermal, photolytic, and hydrolytic conditions were applied on the drug, it was stable. Hence, it can be concluded that the developed RP-UPLC method is economical, precise, and robust and can be adopted in regular Quality control analysis.
采用RP-UPLC定量测定木腥草素,显示出良好的稳定性输出能力。甲壳素是夹竹桃科的一种天然产物,是一种具有抗炎、抗痉挛、抗癌等活性的甾体化合物。切瓦定用作色谱分析的内标。色谱柱为BEH C18 (2.1 × 50 mm, 1.7µm),流动相为乙腈:0.1%正磷酸(60:40),温度为30℃。流速保持在0.3 mL min-1。丁香素和切瓦定的保留率分别为2.005和1。分别是395分钟。回归方程在12.5 ~ 75µg/mL范围内呈良好的线性关系,相关系数为0.999。甲壳素的回收率为100.04%。按照ICH指南关于准确性、敏感性、稳健性和精密度研究的要求进行验证。从流动相、温度和流量变化对分析结果的不显著影响出发,研究了鲁棒性。所有的验证参数都在规范范围内。强制降解研究表明,在酸、碱、过氧化物、热、光解和水解条件的影响下,药物是稳定的。由此可见,所建立的RP-UPLC方法经济、准确、稳健性好,可用于常规的质量控制分析。
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引用次数: 0
Review on statistical methods applied in pharmaceutical quality control and quality assurance 统计方法在药品质量控制和质量保证中的应用综述
Pub Date : 2022-01-30 DOI: 10.14805/jphchem.2022.art122
Aishwarya Karan, Venkatesan Jayaprakash, Manik Ghosh
Global competitions have made the pharmaceutical industry undergo numerous obstacles to meet up with the pace of drug discovery, growth and expansion. In order to effectively manufacture a quality product, statistical methods can be implemented for continuous improvement. Evolution in quality is accessed by determining the beneficial effects due to changes in process performance. The use of statistical tools and statistical methods have increased exponentially to meet specifications of quality during the development of pharmaceutical product. Statistical process control is a segment of industrial statistics utilized for the continuous improvement in the product quality. Statistical process control technique is a method to analyse any variation by the process of timely evaluation of the manufacturing procedure.
全球竞争使制药业经历了许多障碍,以跟上药物发现、增长和扩张的步伐。为了有效地制造高质量的产品,可以采用统计方法进行持续改进。通过确定由于过程性能变化而产生的有益影响,可以获得质量的演变。在药品开发过程中,为了满足质量要求,统计工具和统计方法的使用呈指数级增长。统计过程控制是工业统计的一部分,用于产品质量的持续改进。统计过程控制技术是一种通过对生产过程进行及时评价来分析任何变化的方法。
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引用次数: 0
Implementation of steroidal passport: Experiences of Indian laboratory 类固醇护照的实施:印度实验室的经验
Pub Date : 2021-05-15 DOI: 10.18231/J.IJPCA.2021.006
H. Jamal, Shila Jain, Vandana
The Athlete Biological Passport (ABP) is an indirect approach which provides a complementary and more sophisticated strategy to traditional analytical testing in an effort to scientifically gather evidence of possible doping in sport. The ABP is one tool in a kit of intelligent anti-doping practices meant to deter and detect the use of prohibited substances in sport. In 2013, the WADA Athlete Biological Passport Guidelines introduced a second module, the Steroidal Module, which became operational since January 1, 2014. The Steroidal Module monitors an athlete’s steroidal variables over time that may be indicative of steroid abuse. This paper summarized the details of samples requested for confirmation on GC/C/IRMS in year 2015 & 2016 to understand the pattern of generation of Atypical Passport Finding Confirmation Procedure Request (ATPF-CPR). Interestingly, out of total 26 cases of ATPF-CPR received by NDTL, three samples with normal steroid profile showed exogenous origin of endogenous steroids on GC/C/IRMS analysis,which proves the effectiveness of Steroidal Module. In this context, monitoring of steroid passport through steroidal module represents the new paradigm in detection of exogenous origin of endogenous steroids.Keywords: ABP, Steroid Profile, SSPCPR, ATPFCPR, Endogenous, Exogenous.
运动员生物护照(ABP)是一种间接的方法,它为传统的分析测试提供了一种补充和更复杂的策略,以科学地收集体育运动中可能使用兴奋剂的证据。ABP是智能反兴奋剂措施套件中的一个工具,旨在阻止和检测在体育运动中使用违禁物质。2013年,世界反兴奋剂机构运动员生物护照指南引入了第二个模块,即类固醇模块,自2014年1月1日起开始运行。类固醇模块监测运动员的类固醇变量随着时间的推移,可能表明类固醇滥用。本文总结了2015年和2016年要求在GC/C/IRMS上确认的样品的细节,以了解非典型护照查找确认程序请求(ATPF-CPR)的生成模式。有趣的是,在NDTL接收的26例ATPF-CPR中,有3例正常类固醇谱的样本在GC/C/IRMS分析中显示内源性类固醇的外源性来源,这证明了类固醇模块的有效性。在这种情况下,通过类固醇模块监测类固醇通行证代表了检测内源性类固醇外源性来源的新范式。关键词:ABP,类固醇谱,SSPCPR, ATPFCPR,内源性,外源性。
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引用次数: 0
Overview on capillary electrophoresis with mass spectrometry: Application in peptide analysis and proteomics 毛细管电泳-质谱技术综述:在肽分析和蛋白质组学中的应用
Pub Date : 2021-05-15 DOI: 10.18231/J.IJPCA.2021.002
U. Shah, Aarti Patel, Rutu Patel, Mehul M. Patel, Ashish D. Patel, M. Kavad, Esha Desai
The pharmaceutical industry and most particularly the biopharmaceutical industry are demanding advancements in analytical techniques. The field of proteomics and peptide mapping needs sensitive analysis and sophisticated instrumentation, which needs hyphenated analytical techniques to be explored. In addition to effective detection and characterization, Due to efficient and selective separation, predominant focus has been drawn to capillary electrophoresis/mass spectrometry (CE/MS) compared to widely used techniques such as slab-gel electrophoresis (SGE), liquid chromatography (LC) and capillary electrophoresis (CE) Several significant advances in CE/MS instrumentation and software have madeCE/MS a competitive tool in the last decade to solve a wide variety of analytical and biopharmaceutical problems. This analysis discusses the technological aspects of CE / MS interfaces, analytical separation modes, MS analyzer, recent CE / MS approaches and applications specific to biopharmaceutical. Applications using some of the more common electrophoretic separation modes, such as conventionalelectrophoresis of the capillary zone (CZE) and capillary isoelectric focusing (CIEF), have been highlighted. The peptide analysis also includes recent studies on capillary electro-chromatography (CEC) / MS and CE-MS applications.Keywords: Capillary electrophoresis, Mass spectrometry, Pharmaceutical applications, Peptide analysis, Proteomics, Intact protein.
制药行业,尤其是生物制药行业,要求分析技术的进步。蛋白质组学和多肽图谱领域需要灵敏的分析和精密的仪器,这需要联用分析技术的探索。除了有效的检测和表征外,由于高效和选择性的分离,与广泛使用的平板凝胶电泳(SGE)等技术相比,毛细管电泳/质谱(CE/MS)已成为主要的焦点。在过去十年中,CE/MS仪器和软件的几项重大进展使ece /MS成为解决各种分析和生物制药问题的有竞争力的工具。本分析讨论了CE / MS接口的技术方面,分析分离模式,质谱分析仪,最近的CE / MS方法和特定于生物制药的应用。应用一些更常见的电泳分离模式,如毛细管区常规电泳(CZE)和毛细管等电聚焦(CIEF),已被强调。肽分析还包括毛细管电色谱(CEC) / MS和CE-MS应用的最新研究。关键词:毛细管电泳,质谱,医药应用,肽分析,蛋白质组学,完整蛋白。
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引用次数: 2
Herbal drugs: Boon for Peptic ulcer patients 草药:消化性溃疡患者的福音
Pub Date : 2021-05-15 DOI: 10.18231/J.IJPCA.2021.001
T. Mahato
Antibiotic, antiviral, antifungal and antiparasitic medicines are used to treat the diseases caused by pathogenic microorganisms. These microbes effects humans, animals and plants and produces diseases. As per the recent report of World Health Organization (WHO), the cases of Antimicrobial resistance (AMR) is continuously rising, which causes ineffective treatment and prevention of infections caused by bacteria, viruses, fungi and parasites. AMR occurs when these microbes gets resistance and the medications gets ineffective against these microbes, which makes treatment of common infections difficult and consequently increases the risk of severe illness, spread of disease and death. Because the medicinesbecomes purposeless, infections continue to exist in the body and increases the likeliness of spread to others. WHO recommends reduced use of synthetic antibiotics and raised use of herbal antimicrobial drugs. These are the ways by which the AMR can be controlled or abolished. Herbal drugs can be used for this purpose because these are considered to be effective with no or less side effects. In the present article we discussed about peptic ulcer, causative agent of peptic ulcer and the medicinal plants which can be used to treat this disease. Twenty medicinal plants were listed which contains both antibacterial and antiulcer activity. Due to these properties of these medicinal plants, these can be used for the treatment of pepticulcer because of dual benefits firstly, antibacterial which kills or retards the growth of Helicobacter pylori and secondly, antiulcer which heals the ulcer.Keywords: Antibacterial, Antimicrobial resistance, Antiulcer, Helicobacter pylori, Peptic ulcer.
抗生素、抗病毒、抗真菌和抗寄生虫药物用于治疗由病原微生物引起的疾病。这些微生物影响人类、动物和植物并产生疾病。根据世界卫生组织(世卫组织)最近的报告,抗菌素耐药性(AMR)病例不断上升,导致对细菌、病毒、真菌和寄生虫引起的感染的治疗和预防无效。当这些微生物产生耐药性,药物对这些微生物无效时,抗菌素耐药性就会发生,这使得治疗普通感染变得困难,从而增加了严重疾病、疾病传播和死亡的风险。由于药物变得毫无目的,感染继续存在于体内,并增加了传播给他人的可能性。世卫组织建议减少使用合成抗生素并增加使用草药抗微生物药物。这些都是抗生素耐药性可以被控制或废除的方法。草药可以用于这个目的,因为这些被认为是有效的,没有或很少的副作用。本文就消化性溃疡、消化性溃疡的病原及治疗消化性溃疡的药用植物作一综述。列出了20种具有抗菌和抗溃疡活性的药用植物。由于这些药用植物的这些特性,它们可以用于治疗消化性溃疡,因为它们具有双重功效:第一,抗菌,杀死或延缓幽门螺杆菌的生长;第二,抗溃疡,治愈溃疡。关键词:抗菌药物,耐药性,抗溃疡,幽门螺杆菌,消化性溃疡。
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引用次数: 0
To study the incidence of pre-hospital antibiotic therapy among critically ill patients admitted in rural tertiary care hospital 目的了解农村三级医院危重病人院前抗生素治疗情况
Pub Date : 2021-05-15 DOI: 10.18231/J.IJPCA.2021.007
Guntupalli Suma Geetika, S. Natekar, A. Shetti
There is considerate amount of stress which lies in the application of antibiotics in critically ill patients. A study on pre-hospital antibiotic administration in such patients would provide crucial data and go a long way in determining and understanding trends in antibiotic prescribing, to identify where necessary steps to be taken to improve prescribing are most needed and to measure progress.Materials and Methods:  After ethical committee approval, we have conducted an observational crosssectional study for four months. We collected the data from patient or the relatives regarding prehospital antibiotic therapy on admission.Results: A total of 137 patients got admitted in the Medical intensive care unit (MICU) during the study period. Out of them, 91.24% of patients got admitted directly in MICU and 8.75% were referred from different hospitals. Those who received antibiotics prior to the admission were 2.18% and 93.43% of patients had not received antibiotics; the other patients who were not sure of antibiotic consumption were 4.37%. Among those 2.18% of patients who received, it was observed the most commonly utilized first antibiotic in our study was amoxicillin clavulanate potassium 66.66%. In all the patients that received more than one antibiotic, Metronidazole was the second antibiotic that was administered via intravenous route.Conclusion: Amoxicillin clavulanate potassium was the most commonly and metronidazole was the second most antibiotic prescribed in prehospital admission. Proper guidelines should be initiated for the starting of the antibiotic therapies in India for general practitioners.Keywords: Antibiotics, Incidence, Prehospital, Critically ill.
在危重病人中应用抗生素的压力是相当大的。对这类患者院前抗生素使用情况的研究将提供关键数据,并有助于确定和了解抗生素处方的趋势,确定在哪些地方最需要采取必要步骤改进处方,并衡量进展情况。材料和方法:经伦理委员会批准,我们进行了为期4个月的观察性横断面研究。我们收集了患者或其亲属关于入院前抗生素治疗的资料。结果:研究期间共有137例患者入住内科重症监护病房(MICU)。其中,91.24%的患者直接入住icu, 8.75%的患者转诊至其他医院。入院前接受抗生素治疗的占2.18%,未接受抗生素治疗的占93.43%;不确定抗生素使用情况的占4.37%。在接受治疗的2.18%的患者中,我们的研究中最常用的第一抗生素是阿莫西林克拉维酸钾,占66.66%。在所有接受一种以上抗生素治疗的患者中,甲硝唑是静脉注射的第二种抗生素。结论:院前住院用药以克拉维酸阿莫西林钾最常见,甲硝唑次之。应该为印度全科医生开始抗生素治疗制定适当的指导方针。关键词:抗生素,发病率,院前,危重症
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引用次数: 0
Tuberculous Meningitis with dengue – A rare case 结核性脑膜炎合并登革热-罕见病例
Pub Date : 2021-05-15 DOI: 10.18231/J.IJPCA.2021.005
A. Shetti, P. Ahiwale
A 23-year male patient came to Rural Tertiary Care Hospital with complaints of fever, difficulty in talking, disorientation and neck stiffness and was diagnosed with Dengue. When Dengue antibody testing was done, IgM was positive while IgG and NS1 being negative. We report an evaluation of an IgM seropositive case for dengue who showed neurological manifestation whose MRI Brain suggested Meningitis. CSF examination suggested Tuberculous Meningitis in the course of the infection. The patient responded to medications during hospitalisation, was discharged in a haemodynamically stable condition and was advised to continue with antitubercular treatment and tapering dose of oral steroids. Hence one should not avoid considering a Cerebrospinal fluid examination especially of patients belonging to Dengue endemic areas.Keywords: CSF examination, Dengue, Meningitis, Tuberculosis.
一名23岁男性患者以发热、说话困难、定向障碍和颈部僵硬为主诉来到农村三级保健医院,诊断为登革热。登革抗体检测IgM阳性,IgG和NS1阴性。我们报告了一个IgM血清阳性的登革热病例的评估,该病例显示神经学表现,其MRI脑提示脑膜炎。脑脊液检查提示感染过程中为结核性脑膜炎。患者在住院期间对药物有反应,出院时血流动力学稳定,并建议继续进行抗结核治疗和逐渐减少口服类固醇剂量。因此,不应避免考虑进行脑脊液检查,特别是对属于登革热流行地区的患者。关键词:脑脊液检查,登革热,脑膜炎,肺结核。
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引用次数: 0
Reverse transcriptase inhibitors: Potential drug delivery combating COVID-19 逆转录酶抑制剂:对抗COVID-19的潜在药物输送
Pub Date : 2021-01-15 DOI: 10.18231/J.IJPCA.2020.026
S. Deshpande, D. P. Mali
As the development of any drug and that too antiviral drug always requires time, in this Corona virus pandemic no specific drugs have been approved for coronavirus disease 2019 (COVID-19) till date. Therefore, assessment, analysis and use of currently available antiviral drugs become a challenge for medical field for a timely response to the current pandemic. Here, we have tried review anti CoV-2 potencies of available reverse transcriptase antiviral drugs. Several clinical trials are going on worldwide on variety of options but no specific solution in the form of vaccine or drug developed.Keywords: COVID 19, SARS, Remdesivir.
由于任何药物和抗病毒药物的开发总是需要时间,在这次冠状病毒大流行中,迄今为止尚未批准针对2019年冠状病毒病(COVID-19)的特定药物。因此,评估、分析和使用现有抗病毒药物成为医学界及时应对当前大流行的挑战。在这里,我们尝试审查现有逆转录酶抗病毒药物的抗CoV-2效力。世界各地正在就各种选择进行几项临床试验,但没有以疫苗或药物的形式开发具体的解决方案。关键词:COVID - 19, SARS,瑞德西韦
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引用次数: 1
Validated stability indicating RP-HPLC method for the determination of phenazone and lidocaine hydrochloride in bulk and dosage form 验证了反相高效液相色谱法测定非那酮和盐酸利多卡因原料药和剂型的稳定性
Pub Date : 2021-01-15 DOI: 10.18231/J.IJPCA.2020.028
Charushila J. Bhangale, S. Hiremath
The objective of the present work is to develop a simple, precise, accurate, validated stability indicating RPHPLC method for the determination of Phenazone and Lidocaine hydrochloride in bulk and tablet dosage form. The HPLC separation was achieved on Agilent TC C18 (2) 250 x 4.6 mm, 5 m column using mobile phase composition of phosphate buffer pH 2.5, acetonitrile, Methanol 70:20:10 (V/V/V). Flow rate was maintained at 1.5 ml/min at an ambient temperature. Quantification was achieved with ultraviolet detection at 230 nm. The retention time obtained for Lidocaine hydrochloride was at 7.2 min of and Phenazone was at 10.1 min. The result obtained with the detector response was found to be linear in the concentration range of 50-150 mg/ml for Phenazone and 10-70 mg/ml for Lidocaine Hydrochloride. The reliability and analytical performance of the proposed methods, including linearity, range, precision, accuracy, detection and quantitation limits, were statistically validated. When of Phenazone and Lidocaine hydrochloride was subjected to different stress conditions; the proposed methods could effectively separate the drug from its degradation products, and were thus considered as good stability-indicating procedures. It is concluded that this method can be applied for routine quality control of Phenazone and Lidocaine Hydrochloride in dosage forms as well as in bulk drug.Keywords: Phenazone, Lidocaine hydrochloride, Lidophen ear drop, Method development and validation, Stability indicating.
目的:建立一种简便、准确、可靠、稳定的快速液相色谱法测定盐酸非那酮和利多卡因原料药和片剂的含量。色谱柱为Agilent TC C18 (2) 250 × 4.6 mm,柱长5 m,流动相为磷酸缓冲液pH 2.5,乙腈,甲醇70:20:10 (V/V/V)。在环境温度下,流速保持在1.5 ml/min。在230 nm紫外检测下进行定量。结果表明,在非那酮浓度为50 ~ 150mg /ml、利多卡因浓度为10 ~ 70mg /ml范围内,检测器的响应呈线性关系。方法的可靠性和分析性能,包括线性度、范围、精密度、准确度、检出限和定量限,均得到了统计验证。非那酮和盐酸利多卡因在不同应激条件下的反应;所提出的方法可以有效地将药物从其降解产物中分离出来,因此被认为是良好的稳定性指示方法。该方法可用于非那酮和盐酸利多卡因制剂及原料药的常规质量控制。关键词:非那酮,盐酸利多卡因,利多酚滴耳液,方法开发与验证,稳定性指标
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引用次数: 0
An overview of microcapsule dosage form 微胶囊剂型概述
Pub Date : 2021-01-15 DOI: 10.18231/J.IJPCA.2020.025
Paroma Arefin, Md Shehan Habib, D. Chakraborty, S. Bhattacharjee, Suman Das, Debabrata Karmakar, D. Bhowmik
Microcapsules offer a wide variety of convenience in drug delivery when compared with conventional dosage forms. It is a unique carrier system for many pharmaceuticals. Microencapsulation is a potential process which prolongs the efficacy of drug significantly and improves patient compliance. This approach can alleviate the limitations of dose dumping, multiple dose inconvenience, kidney disease. This dosage form has potential advantages for elderly people who have to take multiple drugs. But microcapsule preparation needs method and formulation optimization and proper characterization. In this review paper, we have discussed the advantages, limitation of the microcapsules and microspheres. We have highlighted the applications of microcapsules and microspheres in the pharmaceutical industries. We also discussed the characterization process of microcapsules. Microcapsules open the era of individualized, targeted drug delivery with minimal side effects and greater convenience.Keywords: Microencapsulation, Microspheres, Microcapsules, Characterization of microspheres, Application of microspheres.
与传统剂型相比,微胶囊在药物输送方面提供了多种便利。它是许多药物的独特载体系统。微胶囊化是一个有潜力的方法,可以显著延长药物的疗效,提高患者的依从性。该方法可减轻剂量倾倒的局限性、多次给药不便、肾脏疾病。这种剂型对需要服用多种药物的老年人有潜在的优势。但微胶囊的制备需要优化方法和配方,并进行适当的表征。本文综述了微胶囊和微球的优缺点。我们重点介绍了微胶囊和微球在制药工业中的应用。我们还讨论了微胶囊的表征过程。微胶囊开启了个体化、靶向给药的时代,副作用最小,更方便。关键词:微胶囊,微球,微胶囊,微球表征,微球应用
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引用次数: 6
期刊
International Journal of Pharmaceutical Chemistry
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