Abstract

RP-HPLC METHOD DEVELOPMENT FOR ESTIMATION OF ROSUVASTATIN IN BULK AND TABLET DOSAGE FORM

Prajakta Aher*

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Abstract

Background: The RP-HPLC method development for rosuvastatin in bulk and tablet dosage form was developed and validated in this research. This was a suitable, clear, accurate and sensitive method for method development of rosuvastatin drug. Acetonitrile: water [75:25 % v/v] was used in concentration sutiable to obtain proper chromatogram. The separation was performed using an HPLC method with a UV detector and Openlab EZchrom program, as well as a Water spherisorb C18 column (100 mm × 4.6; 5m). Acetonitrile was pumped at a flow rate of 0.6 mL/min with a 0.1N NaOH solution balanced to a detected at 252 nm. Result: The developed RP-HPLC method yielded a suitable retention time for rosuvastatin of 3.097 min, which was optimized using the Design Expert-12 software. The linearity of the established method was verified with a correlation coefficient (r2) of 0.999 over the concentration range of 5-40μg/ml.percent recovery was 99.6 to 100.3% respectively. The percentage RSD for the method’s precision was found to be less than 2.0%. The percentage recoveries were discovered to be between 99.5, 100.4, 99.6% respectively for concentration of 80,100,120 μg/mL. Conclusion: The developed and validated RP-HPLC system takes less time and can be used in the industry for routine quality control/analysis of bulk drug and marketed rosuvastatin products.

Keywords: RP-HPLC, QbD, Rosuvastatin, Acetonitrile, Development, Validation, etc.