A Validated Reversed-Phase HPLC Analytical Method for the Analysis of Rosuvastatin Calcium in Bulk Drug and Tablet Dosage Formulation

Journal of Pharmaceutical Research Pub Date : 2021-06-11 DOI:10.9734/JPRI/2021/V33I31A31677

A. Pimpale, R. Kakde

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Abstract

Aims: The current research work has desired the validated reversed-phase analytical technique for the assurance of rosuvastatin calcium in bulk and tablet formulation. Study design: Experimental research work. Place and duration of study: UDPS, RTM Nagpur University, Nagpur, Maharashtra State, India between June 2019 and March 2020. Methodology: The segregation was obtained on a reversed-phase Princeton (C18) column with dimensions (250mm × 4.6mm, 5μ). The solvent system employed was a mixture of buffer, and methanol in the proportion (20:80) v/v, flow rate one ml per minute. Detection wavelength at 240 nm. The retention time (RT)beneath the developed chromatographic condition was found to be 2.848 minutes for rosuvastatin calcium. Results: The technique indicates linearity within the range of 2-16 μg per ml with a correlation Original Research Article Pimpale and Kakde; JPRI, 33(31A): 164-171, 2021; Article no.JPRI.68217 165 coefficient (r) is 0.9999. The analysis of marketed tablet formulations was erect to be 99.98%. The percentage RSD was ˂2% and % recovery was found to be 97.94-100.37%. Conclusion: The advanced reversed-phase HPLC technique was erect to be simple, specific, linear, sensitive, rapid, accurate, precise, economical, and can be utilized for daily quality control of rosuvastatin calcium in tablet and bulk formulations.

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反相高效液相色谱法测定原料药和片剂中瑞舒伐他汀钙的含量

目的:为瑞舒伐他汀钙原料药和片剂处方的质量保证建立有效的反相分析技术。研究设计:实验研究工作。学习地点和时间:2019年6月至2020年3月，印度马哈拉施特拉邦那格浦尔RTM那格浦尔大学UDPS。方法:采用尺寸为250mm × 4.6mm, 5μ的普林斯顿(C18)反相色谱柱进行分离。所采用的溶剂体系为缓冲液和甲醇的混合物，比例为(20:80)v/v，流速为1ml / min。检测波长为240 nm。在建立的色谱条件下，瑞舒伐他汀钙的保留时间为2.848 min。结果:该方法在2 ~ 16 μg / ml范围内呈良好的线性关系;地球物理学报，33(31):164-171,2021;文章no.JPRI。系数(r)为0.9999。市售片剂的分析阳性率为99.98%。RSD值为小于2%，回收率为97.94 ~ 100.37%。结论:先进的反相高效液相色谱技术具有简便、专精、线性、灵敏、快速、准确、精密度高、经济等特点，可用于瑞舒伐他汀钙片剂和散装制剂的日常质量控制。

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来源期刊

Journal of Pharmaceutical Research

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审稿时长

4 weeks