紫外分光光度法测定氯霉唑的方法建立、验证及强制降解研究

Devi velmuruganaƒ, S. Vairavel, Rajasekar chandran, Saranya ., Siva Kumar nayak
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引用次数: 2

摘要

请引用本文:Devi V et al.,紫外分光光度法测定氯霉唑的方法开发、验证及强制降解研究。美国医药技术研究杂志2019。摘要:建立一种简便、精确、准确、稳定的紫外分光光度法测定克霉唑的方法。散装和配方剂型。该方法在国际统一会议(ICH)推荐的不同条件下进行了应力退化试验。生成药物样品并用于降解研究。氯霉唑的λmax为220 nm。氯霉唑在5 ~ 30μg/ml浓度范围内,分别在纯溶液中检验吸光度与浓度的线性关系,相关系数均大于0.999。曲线回归方程为Y = 0.0168x + 0.0041。RSD在ICH指南规定的范围内。结果表明,氯霉唑的回收率在100%±SD范围内。该方法可成功应用于氯霉唑的方法开发、验证和应力降解研究。百分比降解极限应为5-20%。药物氯霉唑被发现在限量之内。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Study Of Method Development, Validation and Forced Degradation Studies of Clotrimazole by Using UV Spectrophotometry
Please cite this article as: Devi V et al., A Study Of Method Development, Validation and Forced Degradation Studies of Clotrimazole by Using UV Spectrophotometry . American Journal of PharmTech Research 2019. A Study Of Method Development, Validation and Forced Degradation Studies of Clotrimazole by Using UV Spectrophotometry Devi velmurugan , Sekar vairavel, Rajasekar chandran, Saranya, Siva Kumar nayak Department of Pharmaceutical Analysis, JKK Nattaraja College of Pharmacy, Komarapalayam, Namakkal (DT), TN, India ABSTRACT To develop a simple, precise, accurate, and stability indicating a UV-method for estimation of Clotrimazole. In bulk and formulated dosage form. The method was under subjected to stress degradation at different conditions recommended by the International Conference on Harmonization (ICH). The drug samples are generated and used for the degradation studies. The λmax of the Clotrimazole was found to be 220 nm. The linearity of calibration curve (Absorbance Vs Concentration) in pure solution was checked over the concentration ranges of about 5-30μg/ml for Clotrimazole respectively, with the correlation coefficient higher than 0.999. The regression equation of the curve was Y = 0.0168x + 0.0041. The % RSD was found to be within the limit as per ICH guidelines. The obtained percentage recovery of Clotrimazole was found to be within the limit 100% ± SD. The proposed method can be successfully applied for the method development, validation and stress degradation studies of Clotrimazole. The percentage degradation limit should be 5-20%. The drug Clotrimazole was found to be within the limit.
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