原料药中阿奇霉素紫外分光光度法的建立及应激降解研究

Sandip Bhimani, G. Sanghvi, T. Pethani, G. Dave, Vishal Airao, Tejas Sharma, N. Sheth, Devendra Vaishnav
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引用次数: 8

摘要

阿奇霉素(AZI)是一种半合成的大环内酯类抗生素药物,对多种细菌有效。本研究描述了一种简单、准确、重现性好、精密度高的紫外分光光度法测定AZI (pH值为6.8的磷酸盐缓冲液)的方法。AZI的吸光度最大值(λmax)为208nm。该方法灵敏度高,在10µg/ml ~ 50µg/ml范围内呈线性关系。检测下限为1.6µg/ml,定量下限为5µg/ml。各校正曲线吸光度与浓度呈线性关系,相关系数均大于0.99。回收率为99.72%。AZI还在国际统一会议(ICH)推荐的不同条件下进行了应力降解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development of the UV Spectrophotometric Method of Azithromycin in API and Stress Degradation Studies
Azithromycin (AZI) is a semi-synthetic macrolide antibiotic drug, effective against a wide variety of bacteria. The present study describes a simple, accurate, reproducible and precise UV Spectrophotometric method for the estimation of AZI (pH 6.8 Phosphate buffer). The absorbance maximum (λmax) for AZI was found to be 208nm. The method reveals high sensitivity, with linearity in the 10 µg/ml to 50 µg/ml range. The lower limit of detection was found to be 1.6µg/ml and the limit of quantification was found to be 5µg/ml. All the calibration curves demonstrated a linear relationship between the absorbance and concentration, with the correlation coefficient higher than 0.99. The % recovery was found to be 99.72%. AZI was also subjected to stress degradation under different conditions recommended by the International Conference on Harmonization (ICH).
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