METHOD DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPY FOR THE ESTIMATION OF EPHEDRINE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL FORMULATION

P. Pravalika, G. Jephthah, A. R. Reddy, T. R. Rao
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Abstract

Development and validation of simple, rapid, accurate, precise and sensitive UV-Spectrophotometric method for the estimation of Ephedrine hydrochloride in bulk drug and Injection dosage form was performed in the current research. Quantitative determination of Ephedrine hydrochloride was done using distilled water as a solvent. λmax of Ephedrine hydrochloride in distilled water was measured at 270 nm. Linearity range for Ephedrine hydrochloride was 2-10 μg/mL and coefficient of correlation for Ephedrine hydrochloride was 0.999. Accuracy was performed and the percentage recovery of Ephedrine hydrochloride was found to be in the range of 98.6-99.17. The % relative standard deviation (RSD) for precision was less than 2%, LOD & LOQ was 0.079 μg/mL and 0.24 μg/mL respectively. The results suggest that method can be employed for routine analysis of Ephedrine hydrochloride in bulk drug and in pharmaceutical Dosage form.
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紫外光谱法测定散装和药物制剂中盐酸麻黄碱含量的方法开发与验证
本研究建立并验证了一种简单、快速、准确、精确和灵敏的紫外分光光度法,用于估算散装药物和注射剂型中盐酸麻黄碱的含量。以蒸馏水为溶剂对盐酸麻黄碱进行定量测定。盐酸麻黄碱在蒸馏水中的λmax 波长为 270 nm。盐酸麻黄碱的线性范围为 2-10 μg/mL,相关系数为 0.999。测定结果表明,盐酸麻黄碱的回收率在 98.6-99.17 之间。精密度的相对标准偏差(RSD)小于 2%,最低检测限和最低定量限分别为 0.079 μg/mL 和 0.24 μg/mL。结果表明,该方法可用于盐酸麻黄碱散剂和药物剂型的常规分析。
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