Asian Journal of Pharmaceutical Analysis最新文献_第6页

UV Spectrophotometric and HPLC Method for Quantification of Ticagrelor in Bulk and Tablet Dosage Form 紫外分光光度法和高效液相色谱法测定替格瑞洛原料药和片剂的含量

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00027

Ravinder Bairam, Hemant Kumar Tatapudi, Neelama Gajji, Shaik Harun Rasheed

{"title":"UV Spectrophotometric and HPLC Method for Quantification of Ticagrelor in Bulk and Tablet Dosage Form","authors":"Ravinder Bairam, Hemant Kumar Tatapudi, Neelama Gajji, Shaik Harun Rasheed","doi":"10.52711/2231-5675.2022.00027","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00027","url":null,"abstract":"The aim of the present investigation was to develop, validate and compare a UV spectrophotometric and a high performance liquid chromatography method for estimating Ticagrelor in bulk and tablet dosage form. Spectrophotometry and high performance liquid chromatography were carried out using standard instrumental parameters, which were optimized. Both methods were validated in terms of linearity, accuracy, precision, robustness, ruggedness and stability according to the ICH guidelines. The optimized ratio of mobile phase in high performance liquid chromatography under low pressure gradient mode was 30:70 % v/v of acetonitrile:glacial acetic acid 1 % , which provide a sharp peak with a short retention time of 3.910 minutes. In UV spectrophotometric analysis iso-propyl alcohol as a solvent gave adequate molar absorptivity at a λmax of 306 nm. Results indicated that both UV spectrophotometric and high performance liquid chromatography methods were linear, precise, accurate, rugged and robust with RSD values less than 2 % and percent recovery was within the standard limits (90-110 %). Both the methods were found to be statistically non-significant at 95 % confidence intervals (p<0.05) with respect to each other. The proposed methods were found to be highly effective and could be used for quantification of Ticagrelor in bulk and a tablet formulations for routine analysis.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"105 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79435482","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: 3

Development and Validation of an RP-HPLC Method for the determination of Safinamide Mesylate in Bulk and Pharmaceutical Dosage Form 反相高效液相色谱法测定甲磺酸沙非胺原料药和制剂含量的建立与验证

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00029

A. Rehman, Pasupathi Nath Tiwari, Sreenivasa Rao

引用次数: 0

A Review on Pharmaceutical Cleaning Validation 药品清洗验证技术综述

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00033

Darshan A. Salade, Kishor S. Arote, P. Patil, Pankaj S. Patil, Amol R. Pawar

引用次数: 1

Analytical Method Development and Validation of Teriflunomide Active Pharmaceutical Ingredient by RP-UHPLC 特立氟米特有效成分反相高效液相色谱分析方法的建立与验证

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00028

Arun Maruti Kashid, Pranali Prakash Polshettiwar, Kshitija Maruti Bhosale

{"title":"Analytical Method Development and Validation of Teriflunomide Active Pharmaceutical Ingredient by RP-UHPLC","authors":"Arun Maruti Kashid, Pranali Prakash Polshettiwar, Kshitija Maruti Bhosale","doi":"10.52711/2231-5675.2022.00028","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00028","url":null,"abstract":"Drug analysis is crucial in the discovery, production, and therapeutic use of pharmaceuticals. Standard analytical procedures for newer medications or formulations may not be available in Pharmacopoeias; thus, newer analytical methods that are accurate, precise, specific, linear, simple, and rapid must be developed. A rapid, simple, sensitive, precise, and cost-effective RP-UHPLC method was developed and validated for the determination of Teriflunomide Active Pharmaceutical Ingredient (API) in this study. The method involved determination of Teriflunomide by resolving on RP-UHPLC using Sunniest C18 (250mm × 4.6mm, 5μm) column, utilizing a mobile phase of ACN: Water in the ratio of 60:40 v/v. The mobile phase was delivered with an isocratic flow rate of 1.0ml/minute. Ultra violet detection was carried out at 210nm. The retention time was optimized to 4. 4 minutes. The linearity range of Teriflunomide 35 to 247µg/ml was found to obey linearity with a correlation coefficient of 0.999. The LOD and LOQ were found to be 1.61µg/ml and 4.90µg/ml respectively and precision data was found to be <2 %RSD. The percentage recovery range was found to be satisfied which is represented in the results. The robustness studies were performed by changing the flow rate and mobile phase compositions. The method was validated for system suitability, specificity, linearity, precision, accuracy, Limit of Detection, Limit of Quantification and robustness. The developed method can be applied for the quality control of commercial teriflunomide API.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84320372","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 UV Spectrophotometric Methods for Simultaneous Estimation of Dolutegravir Sodium and Rilpivirine Hydrochloride in Pure Bulk Form 紫外分光光度法同时测定多替格拉韦钠和盐酸利匹韦林纯度的方法建立与验证

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00031

Sandip T. Thoke, Umesh T. Jadhao, Gunesh N. Dhembre

引用次数: 2

A Brief Review on Titanium Dioxide 二氧化钛的研究进展

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00032

Disha L. Barad, Urvi J. Chotaliya, Nilesh K. Patel

{"title":"A Brief Review on Titanium Dioxide","authors":"Disha L. Barad, Urvi J. Chotaliya, Nilesh K. Patel","doi":"10.52711/2231-5675.2022.00032","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00032","url":null,"abstract":"Titanium Dioxide (TiO2) is widely used in food products and can be found in sauces, icings, and chewing gums as well as in personal care products such as pharmaceutical tablets and toothpaste. Tio2 particle added as a whitening agent to confectionary products, that is, chewing gum, candies, chocolate, and snacks. Titanium dioxide is found naturally in various crystal phases. It exists in different crystal structures. anatase, rutile, and brookite, or a mixture of these. The major routes of TiO2 NP exposure that have toxicological relevance in humans are inhalation, dermal, and oral exposure. for characterization of particle size, size distribution, crystallinity, and concentration of Tio2 particles were first extracted using an acid digestion method from food and separation, various analytical methods were applied. The present study focus on the analyzes qualitative and quantitative trace element by using some analytical methods. TiO2 levels of investigated foods were determined by UV Spectroscopy, Inductively coupled plasma optical emission spectroscopy (ICP-OES), X-ray photoelectron spectroscopy, UV-Visible diffuse reflectance, Raman spectroscopy, Electron microscopy, X-ray diffraction (XRD), Gas volumetry, Laser diffraction, Laser droppler electrophorosis, FT-Raman, Spectroscopic analysis.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74691482","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

Detection of Nicotine by a New System: 一种新的尼古丁检测系统:

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-08-12 DOI: 10.52711/2231-5675.2022.00030

Kamalakshi Krishnamurthy, T. Zin., Priyamvatha K., Mahadeva Rao. U. S., S. M.

引用次数: 0

Implementation of QBD Approach in Analytical Method Development of Fluvastatin by UV-VIS Spectrophotometry QBD法在氟伐他汀紫外-可见分光光度法分析方法开发中的应用

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00016

G. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar

{"title":"Implementation of QBD Approach in Analytical Method Development of Fluvastatin by UV-VIS Spectrophotometry","authors":"G. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar","doi":"10.52711/2231-5675.2022.00016","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00016","url":null,"abstract":"Quality by design (QbD) is a systematic process for pharmaceutical development recommended by regulatory agencies like USFDA. Development of various pharmaceutical processes including analytical methods by applying Quality by design aids in ensuring the robustness of the method. An analytical method was developed for the estimation of fluvastatin by applying QbD approach by UV-VIS spectrophotometry. Solvent 0.1 N NaOH was utilised and 302.4 nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of the drugs was ascertained over the conc range 5-40 mcg/ml (microgram/ml). The accuracy was found within acceptable limit with SD 0.05079-0.78188 %; and the precision study was shown acceptable data as % RSD 0.6259-0.6559 for FVT. The stability of the method was studied by minor variation in the wavelength and minor change in the normality of solvent. The developed method is rigid, robust and efficient for the estimation of FVT from the dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage. The analytical methods, developed based on the QbD concept are more robust and reduce the number of out of trend (OOT) and out of specification (OOS) results during the actual usage in quality control.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88224497","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

Development and Validation of Novel UV Spectroscopy Method for the Estimation of L-Glutathione in Bulk and Formulation with Congo Red 新型紫外光谱法测定原料药和刚果红制剂中l -谷胱甘肽含量的建立与验证

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00014

G. Gajeli, S. Kumbhar, G. Patel

引用次数: 0

Analytical Methods for Estimation of Curcumin in Bulk, Pharmaceutical Formulation and in Biological Samples 散装、制剂和生物样品中姜黄素含量的分析方法

Asian Journal of Pharmaceutical Analysis Pub Date : 2022-05-27 DOI: 10.52711/2231-5675.2022.00025

Ganesh R. Bharskar, S. Mankar, S. Siddheshwar

引用次数: 0