Development and Validation of Analytical methods for estimation of Simvastatin and Fenofibrate

Abstract

The present work describes Stability indicating RP-HPLC and First order derivative UV spectrophotometric method for the quantitative determination of Simvastatin and Fenofibrate. Materials and methods: The parameters Specificity, linearity, accuracy, precision, detection limit, quantitation limit, Robustness and system suitability tests were studied and their results were compiled to ICH guideline Q2 (R2).  Chromatography was carried out by reverse phase technique on an RP-18 with mobile phase composed of Acetonitrile: Water (90:10; %v/v) adjusted to pH 3.3 with 10% orthophosphoric acid) with flow rate 1 ml/min. Both drugs were eluted, isocratically using detection wavelength 230 nm. Methanol was used as a solvent, the spectrum was recorded between 200-400 nm wavelengths, and all the zero-order spectrum (D₀) were converted to first-order derivative spectrum (D₁) using delta lambda 2.0 and scaling factor 4. 240 nm (zero crossing point of Fenofibrate) and 306 nm (zero crossing point of Simvastatin) were used for determination of Simvastatin and Fenofibrate, respectively. Regression analysis of UV-Spectrophotometric method showed good linearity r² = 0.9991 at 240 nm of Simvastatin 1-5 µg/ml and r² = 0.9998 at 306 nm of Fenofibrate 10-50 µg/ml. For proposed methods, the linearity for both methods were obtained in the concentration range of 1-5 μg/ml for Simvastatin and 10-50 μg/ml for Fenofibrate. Statistical analysis by student’s t-test showed no significance difference between the results obtained by these two methods.  Results: The suitability of method for the quantitative determination of Simvastatin and Fenofibrate was proved by validation. Conclusion: The proposed methods and its results had been successfully applied and validated statistically to the simultaneous estimation of Simvastatin and Fenofibrate in their combination for quality analysis