Development and validation of a sensitive RP-HPLC method for simultaneous estimation of Rosuvastatin and Fenofibrate in tablet dosage form by using PDA detector in gradient mode

摘要

Objective: The present work was undertaken with the aim to develop and validate a rapid and consistent RPHPLC method in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Method: RP-HPLC method was developed and validated for simultaneous estimation of Rosuvastatin and Fenofibrate in bulk drug and in combined dosage forms. The HPLC separation was achieved on a XTerra C18 (4.6 X 150mm, 5μm, Make: Thermosil) or equivalent in an Isocratic Mode. The mobile phase was composed of Phosphate Buffer (25%) whose pH was adjusted to 3.0 by using Ortho Phosphoric Acid and Methanol (75%) [HPLC Grade] Results: The flow rate was monitored at 1.0ml per min. The wavelength was selected for the detection was 254 nm. The run time was 7min. The retention time found for the drugs Rosuvastatin and Fenofibrate were 1.997 min., 3.238 min. and 4.042 min. respectively. The % recovery was found to be 98.46%-101.79% for the drug Rosuvastatin. The % recovery was found to be 98.04%-101.79% for the drug Fenofibrate. The linearity was established in the range of 80 to 120ppm for the drug Rosuvastatin and 2.4 to3.6ppm for the drug Fenofibrate. The LOD for the drugs Rosuvastatin and Fenofibrate were found to be 0.07μg/ml, 0.07μg/ml and 0.006μg/ml respectively. The LOQ for the drugs Rosuvastatin and Fenofibrate were found to be 0.23μg/ml, 0.24μg/ml and 0.02μg/ml respectively. Conclusion: The proposed method was adequate sensitive, reproducible, and specific for the determination of Rosuvastatin and Fenofibrate in bulk as well as in Tablet dosage form. The validation of method was carried out utilizing ICH-guidelines. The described RP-HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. Overall the proposed method was found to be suitable and accurate for the Quantitative determination of the drug in Tablet dosage form. The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Rosuvastatin and Fenofibrate in bulk drug and in combined dosage forms.