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

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.