紫外分光光度法测定盐酸罗替戈汀和甲磺酸雷沙吉兰的含量

Q4 Pharmacology, Toxicology and Pharmaceutics

INDIAN DRUGS Pub Date : 2023-05-28 DOI:10.53879/id.60.05.13373

Shivani M. Patel, Lalit L. Jha

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引用次数: 0

摘要

用一阶导数光谱法同时测定了盐酸罗替戈汀和甲磺酸拉沙吉林的含量，建立了一种精确、准确的紫外光谱分析方法。在200-800 nm范围内扫描两种药物的50µg mL-1溶液，并将两种药物一阶光谱重叠以检查过零点。盐酸罗替戈汀在239nm处显示零交叉点，其中甲磺酸拉沙吉林在273nm处显示。六点校准曲线显示，盐酸罗替戈汀在2-12µg mL-1浓度范围内呈线性，甲磺酸拉沙吉林在10-60µg mL-1浓度范围呈线性。获得的两种药物的回归方程被进一步用于准确性研究和开发产品中的浓度测定。在原料药中，甲磺酸拉沙吉林的回收率为98.33-100.93%，盐酸罗替戈汀的回收率在101-103%之间。根据ICH指南对分析结果进行了验证，结果符合要求。

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SIMULTANEOUS UV METHOD DEVELOPMENT FOR DETERMINATION OF ROTIGOTINE HYDROCHLORIDE AND RASAGILINE MESYLATE

A precise, accurate analytical UV spectroscopic method has been developed for simultaneous estimation of rotigotine hydrochloride and rasagiline mesylate by using first order derivative spectroscopy. 50 µg mL-1 solutions of both drugs were scanned in the range of 200-800 nm and the first order overlain spectra of both drugs to check zero crossing points. Rotigotine hydrochloride showed zero crossing point at 239 nm where and rasagiline mesylate showed at 273 nm. Six-point calibration curves shown linearity in 2-12 µg mL-1 concentration range for rotigotine hydrochloride and 10-60 µg mL-1 concentration range for rasagiline mesylate. Regression equation obtained for both drugs were used further for determination of concentration in accuracy studies and developed product. In bulk drugs, rasagiline mesylate showed recovery of 98.33-100.93 % and rotigotine hydrochloride showed recovery of 101-103 %. The results obtained from analysis were validated according to ICH guidelines and were found at up to the mark.

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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