HPTLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF ALECTINIB HYDROCHLORIDE IN BULK POWDER AND CAPSULE PREPARATIONS

Q4 Pharmacology, Toxicology and Pharmaceutics

INDIAN DRUGS Pub Date : 2023-10-28 DOI:10.53879/id.60.10.13519

Shaileshkumar K. Koradia, Rushik P. Thakkar, Ashok N. Mahajan, Falgun A. Mehta, Priyal R. Patel, Digvijaysinh G. Rana

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Abstract

The high performance thin layer chromatography method described here enables simple, accurate and precise estimation of alectinib hydrochloride content in capsule formulation. To achieve adequate separation, G60 - F254 pre-coated silica gel sheets of aluminium were used as the stationary phase. A mobile phase comprising a solvent mixture of methanol and water in a ratio of 80:20 (V/V) was utilized with a chamber saturation duration of 30 minutes. The retardation factor value was found to be 0.47 at the detection wavelength 341 nm. The method’s linearity was confirmed across a concentration range from 600 - 2100 ng band-1, exhibiting a high correlation coefficient of 0.9992. The accuracy range was observed between 98.50 % – 100.45 %. The lowest detection limits of drug were observed to be 17.49 ng band-1 and lowest quantitation limits of drug were found to be 53.01 ng band-1. This developed methodology was effectively employed for the quantification of alectinib hydrochloride in capsule preparations

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hplc法测定盐酸阿勒替尼散装粉剂和胶囊制剂中含量的方法建立及验证

本文所描述的高效薄层色谱法能够简单、准确、精确地测定胶囊制剂中盐酸阿勒替尼的含量。为了达到充分的分离，使用G60 - F254预涂铝硅胶片作为固定相。流动相由甲醇和水的溶剂混合物组成，比例为80:20 (V/V)，室饱和持续时间为30分钟。在检测波长341 nm处，延迟因子值为0.47。该方法在600 ~ 2100 ng波段1的浓度范围内具有良好的线性，相关系数为0.9992。准确度范围为98.50% ~ 100.45%。最低检出限为17.49 ng band-1，最低定量限为53.01 ng band-1。该方法可用于盐酸阿勒替尼胶囊制剂的定量分析

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来源期刊

INDIAN DRUGS Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

0.30

自引率

0.00%

发文量