DEGRADATION ESTIMATION OF ROSUVASTATIN CALCIUM IN PHARMACEUTICAL TABLET FORMULATION

Abstract

Objectives: The present objective was to undertaken the Rosuvastatin Calcium degradation in the tablets formulations with a rapid, economic, consistent, specific and simple analytical procedure.

Methods: The analytical RP-HPLC was validated with mobile phase composition of methyl alcohol : cyanomethane : water  (45:35:20,v/v). The detection was achieved with a flow 1.0 ml/min by using octylsilane column (250 x 4.6 mm, 5 µ), at 248 nm.

Results: The established analytical procedure of Rosuvastatin Calcium was validated statistically for reproducibility, accuracy, specificity as per ICH-guideline. The correlation coefficient was 0.999 with the linearity concentration range 140-260 µg/ml. The percentage recovery was achieved 99.86 to 106.12 and RSD% of precision was 0.599. The specificity was confirmed by excellent photolytic and thermal stability of Rosuvastatin Calcium. The degradation statistical recovery of Rosuvastatin Calcium in dry, wet and thermal stage ware 99.25%, 99.52 % and 99.64% respectively validated. The developed peaks in the chromatograms of alkali, oxidation and acid decomposition of Rosuvastatin Calcium were confirmed by screening the degradation peaks and the recovery percentage were found 23.16 %, 85.59 % and 66.33 % respectively.

Conclusions: The stress conditions of Rosuvastatin Calcium in degradation study is successfully developed and it is also important in stability to determined the highest lipid lowering agent in the body that block the manufacturing of cholesterol. The stress conditions like in aqueous acidic hydrolysis, oxidative, alkaline hydrolysis, thermal and photolytic degradation study was validated with a simple, cost efficient, linear, accurate, selective, specific, high performance liquid chromatography with a simple effortless mobile phase containing methyl alcohol, cyanomethane and water.