Development and Validation of Analytical Method for the Estimation of Trihexphenidyl and Trifluoperazin in Bulk and Combination Dosage form by RP-HPLC

Developed an accurate, precise and reproducible high performance liquid chromatographic method for simultaneous estimation of Trihexphenidyl and Trifluoperazin in bulk and tablet dosage forms. Chromatographic separations of the drugs were achieved on a Symmetry ODS C18 (4.6×150mm, 5.0 µm) using a mobile phase consisting of Methanol: TEA Buffer pH-4.8 (35:65) v/v at a flow rate of 1.0 ml/min. The drugs elute were monitored at 276 nm. The retention time obtained for the Trihexphenidyl was 2.090 min and for the Trifluoperazin was 5.289 min. The calibration curves were linear over the range of 20- 60μg/ml and 25-75μg/ml for Trihexphenidyl and Trifluoperazin respectively. The method is validated as per ICH guideline by determining its specificity, accuracy, precision, linearity & range, ruggedness, robustness and system suitability. The results of the study show that the proposed method is simple, rapid, precise and accurate, which is useful for the routine determination of Trihexphenidyl and Trifluoperazin in bulk and tablet dosage forms. The method could be applied for determination of in its tablet dosage forms without any interference from excipients or endogenous substances. The proposed method is suitable for routine quality control analysis.