A Double Divisor Ratio-Spectra Derivative Method for the Ternary Mixture of Aspirin, Clopidogrel Bisulphate and Rosuvastatin Calcium

Abstract

Quantitative analysis of formulation containing Aspirin, Clopidogrel Bisulphate and Rosuvastatin Calcium were performed using double divisor ratio spectra derivative method. Detection wavelength for Aspirin, Clopidogrel Bisulphate and Rosuvastatin Calcium was 240.2 nm, 231.8 nm and 263.2 nm respectively. The linearity range for all three drugs was 2-20 μg/mL and it was validated through regression analysis and residual analysis. Mean percentage recovery was 100.09 %, 100.60 % and 99.86 % for Aspirin, Clopidogrel Bisulphate and Rosuvastatin Calcium respectively. The developed method was validated according to International Council for Harmonization guidelines and validation approach is much more justified than the usual approach. The use of advanced statistical tools for validation ensures the efficiency; quality and reproducibility of our method. Obtained results were satisfactory and ensured the quality and reproducibility of the method.

GRAPHICAL ABSTRACT

Keywords:

• Double divisor ratio spectra method
• Aspirin
• Clopidogrel Bisulphate
• Rosuvastatin Calcium
• ICH Guidelines
• Method Development and validation