DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR PIMAVANSERIN TARTRATE

International Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2023-10-01 DOI:10.22159/ijpps.2023v15i10.48820

MRINALINI C. DAMLE, ROSHANI R. PARDESHI, SHUBHANGI R. BIDKAR

{"title":"DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR PIMAVANSERIN TARTRATE","authors":"MRINALINI C. DAMLE, ROSHANI R. PARDESHI, SHUBHANGI R. BIDKAR","doi":"10.22159/ijpps.2023v15i10.48820","DOIUrl":null,"url":null,"abstract":"Objective: The aim of current research work was to investigate degradation behavior of Pimavanserin tartrate upon exposure to stress conditions recommended by ICH Q1A (R2) and Q1B guidelines. Methods: Chromatographic separation was achieved on Merck’s TLC aluminum plates pre-coated with silica gel G 60 F254 as stationary phase and Methanol: Chloroform (2:8 v/v) as mobile phase. Densitometry scanning was carried out at 224 nm. Results: The retardation factor (Rf) was observed to be 0.56±0.02. Pimavanserin tartrate showed degradation in all stress conditions, but no degradation product was found in any stress condition. Peak purity was found to be 0.999 indicating no interference by degradation products to drug peak. The developed HPTLC method was successfully validated as per ICH Q2 (R1) guideline. Method was found to be linear within the range of 400-2000 ng/band with correlation coefficient R2= 0.9982. % RSD for intra-day and inter-day precision were found to be 1.35 and 1.78 % and % recovery was found to be in range 98-102 %. LOD and LOQ were found to be 17.58 ng/band and 53.27 ng/band respectively. Conclusion: A simple, economic stability indicating high performance thin layer chromatography method has been developed and validated for Pimavanserin tartrate. It is used for the treatment of delusions and hallucinations in Parkinson’s disease.","PeriodicalId":14188,"journal":{"name":"International Journal of Pharmacy and Pharmaceutical Sciences","volume":"20 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmacy and Pharmaceutical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.22159/ijpps.2023v15i10.48820","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

Abstract

Objective: The aim of current research work was to investigate degradation behavior of Pimavanserin tartrate upon exposure to stress conditions recommended by ICH Q1A (R2) and Q1B guidelines. Methods: Chromatographic separation was achieved on Merck’s TLC aluminum plates pre-coated with silica gel G 60 F254 as stationary phase and Methanol: Chloroform (2:8 v/v) as mobile phase. Densitometry scanning was carried out at 224 nm. Results: The retardation factor (Rf) was observed to be 0.56±0.02. Pimavanserin tartrate showed degradation in all stress conditions, but no degradation product was found in any stress condition. Peak purity was found to be 0.999 indicating no interference by degradation products to drug peak. The developed HPTLC method was successfully validated as per ICH Q2 (R1) guideline. Method was found to be linear within the range of 400-2000 ng/band with correlation coefficient R2= 0.9982. % RSD for intra-day and inter-day precision were found to be 1.35 and 1.78 % and % recovery was found to be in range 98-102 %. LOD and LOQ were found to be 17.58 ng/band and 53.27 ng/band respectively. Conclusion: A simple, economic stability indicating high performance thin layer chromatography method has been developed and validated for Pimavanserin tartrate. It is used for the treatment of delusions and hallucinations in Parkinson’s disease.

查看原文本刊更多论文

酒石酸匹马万色林hplc稳定性测定方法的建立与验证

目的:研究ICH Q1A (R2)和Q1B指南所推荐的应激条件下酒石酸皮马万色林的降解行为。方法:采用以硅胶G 60 F254为固定相，甲醇:氯仿(2:8 v/v)为流动相，预先包被的默克薄层色谱铝板进行色谱分离。在224 nm处进行密度扫描。结果:延迟因子(Rf)为0.56±0.02。酒石酸皮马万色林在所有胁迫条件下均有降解，但在任何胁迫条件下均未发现降解产物。峰纯度为0.999，表明降解产物对药峰无干扰。根据ICH Q2 (R1)指南成功验证了所建立的hplc方法。结果表明，该方法在400 ~ 2000 ng/波段范围内线性良好，相关系数R2= 0.9982。日内和日内精密度的RSD分别为1.35%和1.78%，回收率在98 ~ 102%之间。LOD和LOQ分别为17.58 ng/band和53.27 ng/band。结论:建立了一种简便、经济、稳定的高效薄层色谱法测定酒石酸皮马万色林。它用于治疗帕金森氏症的妄想和幻觉。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

International Journal of Pharmacy and Pharmaceutical Sciences

自引率

0.00%

发文量