Development and validation of a RP-HPLC-PDA method for simultaneous estimation of Drotaverine and Etoricoxib in tablet and its application for dissolution studies
By P. K. Syal, M. Sahoo, K. D. Ingale, S. S. Ingale, V. P. Choudhari and B. S. Kuchekar
A simple, precise, rapid and accurate RP-HPLC-PDA method has been developed for the simultaneous estimation of Drotaverine HCl (DRT) and Etoricoxib (ETR) in tablet formulations. The chromatographic separation was achieved on Waters Kromosil C18 column (250 mm x 4.6 mm, 5.0 μ particle size) using methanol: THF: acetatebuffer (51:09:40 v/v) pH adjusted to 6.0 with acetic acid, flow rate was 0.9ml/min and column was maintained at 55 0C. Quantification and linearity was achieved at 244 nm over the concentration range of 1.6 – 80µg/ml for Drotaverine HCl and 1.8 – 90µg/ml for Etoricoxib. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines. Method was used to test dissolution sample successfully. Thiocolchicoside and Hydrochlorthiazide were used as internal standard.
Key words: Drotaverine, Etoricoxib, RP-HPLC-PDA, method validation, column liquid chromatography, dissolution.