Monali G. Patel*, Ragin R. Shah, Krupa H. Shah, Bushra M. Malik
Department of Pharmacy, Pharmaceutical Quality Assurance Laboratory,
Arihant School of Pharmacy & BRI, Adalaj,
Gandhinagar-382421, Gujarat, India.
A simple, novel, sensitive, precise and specific validated RP-HPLC method was developed for simultaneous determination of Tolperisone Hydrochloride (TOL) and Paracetamol (PCM) in Pharmaceutical Formulation (Tablet). The chromatographic separation was achieved on C18 Licrosphere column as a stationary phase usingMethanol: Tetrahydrofuran (90: 10 v/v, pH 8.2 with 0.1% v/v TEA) as mobile phase at detection wavelength 254 nm. The linearity range was 3-27 µg/ml for TOL and 10-90 µg/ml for PCM with Rt of 3.593 min and 5.023 min for PCM and TOL respectively. The correlation coefficient (r) values were found to be found to be 0.9994 and 0.9998 for TOL and PCM, respectively.Precision study showed % CV values less than 2% for both TOL and PCM, respectively in all selected concentrations. The % Recoveries of TOL and PCM are in the range of 99.96- 100.71 % and 99.73- 100.49 %, respectively. The assay results of TOL and PCM are 100.05 % and 99.98 %, respectively. This is comparable to labeled claim. The method was validated as per the International Conference on Harmonization (ICH) guidelines.The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.