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A new simple RP-HPLC Method development, Validation and Forced degradation studies of Bilastine 一种新的反相高效液相色谱(RP-HPLC)方法的建立、验证及强制降解研究
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00031
Khushbu K. Patel, A. Patel, C. N. Patel
A new simple, rapid, accurate and precise method for estimation of Bilastine in pharmaceutical dosage form by reverse phase liquid chromatography. The developed method employed mobile phase was Acetonitrile and Ammonium acetate pH 5.0 adjusted with glacial acetic acid with 85:15% v/v and flow rate 1.0ml/min. Method was developed using column C18 Water (150 × 4.6mm, 5µm) and detection wavelength was 215nm. The retention time was found to be 2.519 min. the proposed method was successfully applied to the determination of Bilastine in dosage form. High linearity of developed method was confirmed over concentration range of 25- 150 µg/ml and co-relation co-efficient is 0.996. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The recovery was in the range of 99 – 102% and limit of detection was found to be 0.45µg/ml and limit of quantification was found to be 1.20µg/ml. Bilastine was found to degrade under acid and oxidation conditions. There was no interference of excipient and degradation product in retention time so method was specific. Analytical parameter such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to international Conference on Harmonization (ICH) guidelines.
建立了一种简便、快速、准确、精密的反相液相色谱法测定药物剂型中胆碱含量的新方法。流动相为乙腈-乙酸铵,pH 5.0,冰醋酸调节,85:15% v/v,流速1.0ml/min。方法采用C18 Water柱(150 × 4.6mm, 5µm),检测波长215nm。保留时间为2.519 min,该方法可用于比拉斯汀制剂的测定。在25 ~ 150µg/ml浓度范围内线性良好,相关系数为0.996。该方法精密度和准确度的RSD百分比小于2%。加样回收率为99 ~ 102%,检出限为0.45µg/ml,定量限为1.20µg/ml。发现Bilastine在酸和氧化条件下降解。该方法不受辅料和降解产物对保留时间的干扰,具有专属性。精密度、准确度、检出限、定量限和鲁棒性等分析参数根据国际协调会议(ICH)的指导方针确定。
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引用次数: 4
A Precise Review on Applications and Basic Concept of Direct Analysis in Real Time Mass Spectrometry (DART-MS) 实时质谱(DART-MS)直接分析的基本概念及应用综述
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00042
Shivani Sharma, Navdeep Singh, A. Ankalgi, Arti Rana, M. Ashawat
Direct real time analysis (DART) is the most successful tool for the analysis of the compounds. This technique is useful for the identification, and classification of compounds. It is widely followed by the forensic chemistry, and also used for many purposes. Their main applications include inks, paints, drugs, bank dyes, explosives, beverages, and gunshot etc. The basic concepts of DART-MS were highlighted to understand the process. Also the basic fundamentals of DART-MS including special function were discussed. Various natural products were discovered by DART-MS includes plant tissue, insects, and microbe etc. The main focus of this review article is on the applications of direct real time analysis, which covers the varieties of uses in our pharmaceutical as well as chemical industries. This technique was helpful in the production of food material, and to identify the contaminants from animal sources in the part of veterinary drugs. Also, used in food processing in the form of additives, and adulterants. DART-MS has huge applications on analysis of seized drug like steroids supplements, psychoactive plants etc. Also, in inks, paint, and documents industry this technique has been widely used. So, this review covers the basic fundamentals of direct real time analysis DART-MS, and their applications.
直接实时分析(DART)是最成功的化合物分析工具。这项技术对化合物的鉴定和分类是有用的。它被法医化学广泛采用,也用于许多目的。其主要用途包括油墨、油漆、药物、银行染料、炸药、饮料和射击等。强调了DART-MS的基本概念,以了解其过程。讨论了DART-MS的基本原理和特殊功能。DART-MS发现了多种天然产物,包括植物组织、昆虫、微生物等。本文主要介绍了直接实时分析技术在制药和化学工业中的应用。该技术有助于食品原料的生产,以及兽药部分动物源污染物的鉴定。此外,在食品加工中以添加剂和掺假的形式使用。DART-MS在分析缉获药物如类固醇补充剂、精神活性植物等方面有着巨大的应用。此外,在油墨、油漆和文件工业中,这种技术也得到了广泛的应用。本文就直接实时分析技术DART-MS的基本原理及其应用作一综述。
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引用次数: 1
To Estimate the Label claim of tablet in their combination by simultaneous estimation using UV-Visible Spectrophotometric method 用紫外可见分光光度法同时估计片剂在其组合中的标签要求
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00033
D YelekarP, Chaudhari S.B, D ChourasiaR, R TikariyaK, B. Payal
Objective: The main objective of the work was to check the label claim of tablet in combination by Simultaneous estimation by UV method. Method: Spectrophotometric method development and validation are plays important role in the development and manufacture of pharmaceuticals. This Spectrophotometric method was a simple and reproducible for the quantitative determination of Paracetamol and Caffeine in tablet formulation was developed and validated in the present work. The various parameters like specificity, linearity, precision, accuracy, robustness and ruggedness were studied according to ICH guidelines. The wavelength 273nm was selected for the estimation of Caffeine using distilled water as a solvent and the wavelength 243nm selected for the estimation of Paracetamol using distilled water as solvent the drug obeyed Beer’s-Lambert’s law over the concentration range 20-120µg/ml. Recovery study was performed to confirm the accuracy of the method. The method was successfully applied for routine analysis of this drug in formulation the method were validated as pr ICH guidelines. Conclusion: A simple UV spectrophotometric method was developed for the Simultaneous determination of Paracetamol and Caffeine in tablet formulation without any interference from the excipients. The present method succeeded in adopting a simple sample preparation that achieve satisfactory extraction recovery and facilitated its application in co formulated formulation.
目的:采用紫外分光光度法对复方片剂的标签要求进行校核。方法:分光光度法的开发和验证在药品的开发和生产中起着重要的作用。建立了测定片剂中对乙酰氨基酚和咖啡因含量的分光光度法,该方法简便、重复性好。根据ICH指南对特异性、线性、精密度、准确度、稳健性和坚固性等参数进行了研究。以蒸馏水为溶剂测定咖啡因的波长选择273nm,以蒸馏水为溶剂测定对乙酰氨基酚的波长选择243nm。在20 ~ 120µg/ml浓度范围内,药物符合比尔-兰伯特定律。回收率研究证实了该方法的准确性。该方法成功地应用于该制剂的常规分析,并按照ICH指南进行验证。结论:建立了一种不受辅料干扰的紫外分光光度法同时测定片剂中对乙酰氨基酚和咖啡因含量的方法。本方法采用简单的样品制备方法,取得了满意的萃取回收率,便于在共配制剂中应用。
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引用次数: 0
Validated RP-HPLC method for the estimation of Amiloride and hydrochlorothiazide in combined tablet dosage form 验证了联合片剂中阿米洛利和氢氯噻嗪含量的反相高效液相色谱法
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00037
R. Kumar, G. R. Babu, M. Sowjanya, M. Ramayyappa
The aim of this work is to build up a fast, exact, precise and touchy reverse phase liquid chromatographic method for the synchronous assessment of amiloride and hydrochlorothiazide in tablet dose structure. The chromatographic strategy was normalized utilizing Hypersil ODS segment (250×4.6mm, 5μm molecule size) with UV discovery at 210nm and stream pace of 1ml/min. The portable stage includes phosphate buffer (pH acclimated to 2.5 with dilute Ortho Phosphoric acid) and acetonitrile in the proportion of 60:40 v/v. The linearity of proposed technique was examined in the scope of 5-30μg/ml (R²=0.999) for amiloride and 50-300μg/ml (R²=0.999) for Hydrochlorothiazide appropriately. The limit of detection (LOD) was discovered to be 0.10μg/ml and 0.40μg/ml for Amiloride and Hydrochlorothiazide appropriately. The limit of quantitation (LOQ) was discovered to be 0.30μg/ml and 1.20μg/ml for Amiloride and Hydrochlorothiazide separately. The retention times of Amiloride and Hydrochlorothiazide were found to be 3.258min and 2.383min separately. The technique was truly recommended and %RSD was found to be under 2 demonstrating serious level of exactness and accuracy. Subsequently proposed strategy can be effectively evaluated for the synchronous assessment of Amiloride and Hydrochlorothiazide in promoted formulations.
本研究旨在建立一种快速、准确、精密、灵敏的反相液相色谱法,用于同时测定阿米洛利和氢氯噻嗪片剂的剂量结构。色谱策略采用Hypersil ODS段(250×4.6mm, 5μm分子大小)进行归一化,紫外发现波长为210nm,流速为1ml/min。便携式阶段包括磷酸盐缓冲液(pH为2.5,用稀邻磷酸驯化)和乙腈,比例为60:40 v/v。在阿米洛利5 ~ 30μg/ml (R²=0.999)和氢氯噻嗪50 ~ 300μg/ml (R²=0.999)范围内考察了该方法的线性关系。阿米洛利和氢氯噻嗪的检出限分别为0.10μg/ml和0.40μg/ml。阿米洛利和氢氯噻嗪的定量限分别为0.30μg/ml和1.20μg/ml。阿米洛利和氢氯噻嗪的保留时间分别为3.258min和2.383min。该技术得到了真正的推荐,并且发现%RSD低于2,显示出严重的准确性和准确性。由此提出的策略可有效评价推广配方中阿米洛利和氢氯噻嗪的同步评价。
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引用次数: 3
A Review on Metal Impurities in Pharmaceuticals 药物中金属杂质研究进展
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00038
A. Patel, Avadhi R. Bundheliya, A. Vyas, Nilesh Patel, Ajay I. Patel, Arvind N. Lumbhani
Sources of metal impurities can from anywhere in drug product as raw material which may produce using metal catalyst, excipients, process materials, Water or any solvent used, manufacturing equipment, environment, packaging materials. So, it leads to metal impurity in high amount present in final drug product that is why it is important to check the impurity level in final drug product or as well as in process also that it should be present in low or acceptable amount. Any Drug product is not completely pure, some amount of metal impurities are always present in pharmaceutical product may cause various toxicity when it will be administered. Thus it is necessary to check impurity level is present at acceptable amount. The present review gives an account of updated information about metal impurities and reviews the regulatory aspects for such metal impurities in drug substance/drug product. In addition the aim of this article is to discuss the currently used different analytical techniques for detection of metals from drug product like spectrophotometry, X – Ray florescence spectrometry, AAS, INAA, ICP – AES, ICP – MS, MP – AES, Laser Ablation – ICP – MS etc which is used for quality control of metal impurities in pharmaceuticals.
金属杂质的来源可以从药品的任何地方作为原料,生产中可能使用金属催化剂、辅料、工艺材料、水或任何溶剂、制造设备、环境、包装材料等。因此,它会导致最终药品中出现大量的金属杂质,这就是为什么检查最终药品中的杂质水平很重要,以及在过程中,它应该以低或可接受的量存在。任何药品都不是完全纯净的,一定数量的金属杂质总是存在于药品中,在给药时可能会引起各种毒性。因此,有必要检查杂质水平是否存在于可接受的量。本综述介绍了金属杂质的最新信息,并综述了原料药/制剂中金属杂质的监管方面。此外,本文还讨论了目前用于药品金属杂质质量控制的各种分析技术,如分光光度法、X射线荧光光谱法、原子吸收分光光度法、原子吸收光谱法、原子吸收光谱法、ICP - AES法、ICP - MS法、MP - AES法、激光烧蚀- ICP - MS法等。
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引用次数: 9
UV Spectrophotometric Method Development and Validation of Dasatinib in Bulk and Formulation 达沙替尼原料药和制剂的紫外分光光度法开发与验证
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00036
Jyoti Mittha, Bhavana Habib
UV-Spectrophotometric method has been developed and validated for quantitative estimation of dasatinib in bulk and pharmaceutical formulation. Dasatinib is soluble in acetonitrile, so it was used as solvent. Dasatinib was dissolved in acetonitrile and resulting solution was scanned in UV range (200-400nm). The λmax was found to be 315nm. Beers law is valid in concentration range of 5-25µg/ml. The developed method was validated for linearity, accuracy, precision, robustness; LOD and LOQ. Linearity was obtained in the range of 5-25µg/ml with correlation coefficient 0.9992. LOD and LOQ were found to be 0.908µg/ml and 2.752µg/ml respectively. The method showed good reproducibility and recovery so; proposed method can be applied for routine analysis of dasatinib in bulk and pharmaceutical formulation.
建立并验证了紫外分光光度法对达沙替尼原料药和制剂的定量评价。达沙替尼可溶于乙腈,所以用它作为溶剂。将达沙替尼溶解于乙腈中,在200-400nm紫外波段扫描。λmax为315nm。比尔斯定律在5-25µg/ml的浓度范围内有效。对该方法进行了线性度、准确度、精密度、鲁棒性验证;LOD和LOQ。在5 ~ 25µg/ml范围内呈线性关系,相关系数为0.9992。定量限和定量限分别为0.908µg/ml和2.752µg/ml。方法重现性好,回收率高;该方法可用于达沙替尼原料药和制剂的常规分析。
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引用次数: 4
A Review article on Analytical Method Development for the combination of Azelnidipine and Telmisartan 阿泽尼地平与替米沙坦联用分析方法的研究进展
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00040
Nirma Chavda, Suresh Kumar
The literature survey explains that there is not any stability indicating method reportedly for combination of Azelnidipine and Telmisartan till date. Validation and development of stability indicating analytical methods is possible as per ICH Guidelines. There are several of Spectroscopic methods such as Ultraviolet Spectroscopy, Mass spectroscopy, infrared spectroscopy, Nuclear magnetic resonance spectroscopy and Chromatographic methods such as High performance liquid chromatography, Thin layer Chromatography, High Performance thin layer chromatography, Gas chromatography and Ultra performance liquid chromatography etc. used for stability indicating method development and validation.
文献调查表明,迄今为止,阿泽尼地平与替米沙坦合用的稳定性指标尚未见报道。根据ICH指南,可以验证和开发稳定性指示分析方法。用于稳定性指示方法开发和验证的光谱方法有紫外光谱法、质谱法、红外光谱法、核磁共振光谱法等,色谱方法有高效液相色谱法、薄层色谱法、高效薄层色谱法、气相色谱法和超高效液相色谱法等。
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引用次数: 7
Development and Validation of UV Spectroscopy Method for the Estimation of Dolutegravir in Bulk and Pharmaceutical Dosage Form 紫外光谱法测定原料药和制剂中多替格拉韦含量的建立与验证
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00032
Vaishnavi Dulange, G. Gajeli
UV spectroscopic method was developed for the estimation of Dolutegravir in bulk and Formulation.The UV spectrum of Dolutegravir in methanol and water mixture showed λ max at 254nm. Beer’s law is valid in the concentration range of 10-50µg/ml. This method was validated for linearity, accuracy, precision, LOD and LOQ. The method has demonstrated excellent linearity over the range of 10-50µg/ml with regression equation y = 0.030x + 0.008 and regression correlation coefficient r2= 0.998. Moreover, the method was found to be highly sensitive with LOD (2.056μg/ml) and LOQ (6.230μg/ml). Depending on results the given method can be successfully applied for assay of Dolutegravir in formulation.
建立了紫外分光光度法测定多替替韦原料药和制剂的含量。Dolutegravir在甲醇和水混合物中的紫外光谱在254nm处出现λ max。Beer定律在10-50µg/ml的浓度范围内有效。对该方法进行了线性度、准确度、精密度、定量限和定量限的验证。该方法在10 ~ 50µg/ml范围内线性良好,回归方程为y = 0.030x + 0.008,回归相关系数r2= 0.998。检测限为2.056μg/ml,定量限为6.230μg/ml,具有较高的灵敏度。结果表明,该方法可成功地应用于制剂中多替格拉韦的含量测定。
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引用次数: 2
Evaluation of Cancer Bio-markers through Hyphenated Analytical Techniques 用连字符分析技术评价肿瘤生物标志物
Pub Date : 2021-08-16 DOI: 10.52711/2231-5675.2021.00041
Ch. Prudhvi Raju, G. R. Babu, S. M., Ramayyappa M.
Background: The accurate and efficient diagnosis at the early stages of cancers is the key feature for effective treatment and productive research for finding out news to types of cancers. It is essentially true for cancers, where there is no effective cure, but only one treatment is available. But most people have a combination of treatments, such as surgery with chemotherapy or radiation therapy or immunotherapy or targeted therapy or hormone therapy.Cancers symptoms of abnormal periods or pelvic pain, changes in bathroom habits, bloating, breast changes, chronic coughing, chronic headache, difficulty swallowing, excessing bruising. Despite the fact of having great need, the current availability of diagnostic tests is unable to diagnose different forms of cancers. Aim: The aim of the review is to explore the application of GC-MS, LC-MS and UP-LC/Q-TOF MS for the evaluation of changes in the biochemical composition of blood serum, urine and saliva. The power of high differentiation method will promote the translation of hyphenated techniques from a laboratory to clinical useful tool. Determination of biochemical information derives from hyphenated techniques from blood, serum, saliva and urine that will yield accurate and selective detection of cancer disorders. They will also provide diagnostic and prognostic indicators and will also play a significant role in the development of personalized medicine. Conclusion: Hyphenated techniques will allow differentiating blood serum, saliva and urine samples of common cancer disorders from normal control patients with sensitivity and specificity.
背景:癌症早期准确、高效的诊断是有效治疗和高产研究的关键。对于癌症来说,这基本上是正确的,因为没有有效的治疗方法,但只有一种治疗方法可用。但大多数人都有联合治疗,比如手术和化疗、放射治疗、免疫治疗、靶向治疗或激素治疗。月经异常或盆腔疼痛的癌症症状,卫生间习惯的改变,腹胀,乳房变化,慢性咳嗽,慢性头痛,吞咽困难,过度瘀伤。尽管有很大的需求,但目前可用的诊断测试无法诊断不同形式的癌症。目的:探讨GC-MS、LC-MS和UP-LC/Q-TOF MS在评价血清、尿液和唾液生化成分变化中的应用。高分化方法的力量将促进连字符技术从实验室到临床有用的工具的翻译。生化信息的测定源于血液、血清、唾液和尿液的连字符技术,这将产生准确和选择性的癌症疾病检测。它们还将提供诊断和预后指标,并将在个性化医疗的发展中发挥重要作用。结论:用连字符技术区分常见肿瘤患者的血清、唾液和尿液具有敏感性和特异性。
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引用次数: 1
Development and Validation of RP-HPLC Method for Analysis of Aclidinium Bromide and Formoterol Fumarate in Pharmaceuticals 反相高效液相色谱法测定药品中溴化吖啶和富马酸福莫特罗含量的建立与验证
Pub Date : 2021-05-13 DOI: 10.52711/2231-5675.2021.00012
Devadasu Ch., Bharani
{"title":"Development and Validation of RP-HPLC Method for Analysis of Aclidinium Bromide and Formoterol Fumarate in Pharmaceuticals","authors":"Devadasu Ch., Bharani","doi":"10.52711/2231-5675.2021.00012","DOIUrl":"https://doi.org/10.52711/2231-5675.2021.00012","url":null,"abstract":"","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"159 1","pages":"63-69"},"PeriodicalIF":0.0,"publicationDate":"2021-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75683834","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: 0
期刊
Asian Journal of Pharmaceutical Analysis
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