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 coefficient (r2) 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.
Highlights
Rosuvastatin calcium, chemically (3R,5R)-7-[4(4-Fluorophenyl)-2[methyl(methylsulfonyl)amino]-6-propan-2ylpyrimidin-5-yl]-3,5-dihydroxyhept-6enoic acid (Fig. 1)
This paper reports an approved Reversed Phase-HPLC technique for the determination of rosuvastatin calcium
Linearity test solutions of rosuvastatin calcium were arranged by diluting the stock solution at concentration levels of [2-16] μg/ml
Summary
Rosuvastatin calcium, chemically (3R,5R)-7-[4(4-Fluorophenyl)-2[methyl(methylsulfonyl)amino]-6-propan-2ylpyrimidin-5-yl]-3,5-dihydroxyhept-6enoic acid (Fig. 1). It is used as an antilipidemic agent in the dealing of abnormal lipid, hypertension [1,2]. The literature review revealed that several highperformance liquid chromatography techniques were notified for the evaluation of rosuvastatin calcium in tablet and bulk formulations. This paper reports an approved Reversed Phase-HPLC technique for the determination of rosuvastatin calcium. The suggested technique is very simple, rapid& suitable for the routine evaluation of rosuvastatin calcium in tablet and bulk formulations. As per ICH guidelines (ICH, Q2A; ICH, Q2B), the method was developed
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