STABILITY INDICATING UPLC METHOD FOR QUANTIFICATION OF TOLPERISONE HCL AND PARACETAMOL FROM MUSCLE RELAXANT COMBINATION TABLET
Objective: In the present work, rapid and sensitive isocratic RP-UPLC method was established and comprehensive validation study for the estimation of Tolperisone HCl and Paracetamol was carried out according to international conference on harmonization (ICH) guidelines.
Methods: Simultaneous estimation was chromatographed using 0.1% o-phosphoric acid in water and acetonitrile (70: 30 v/v) as a mobile phase at a flow rate of 0.20 ml/min with 35 ÂºC column temperature. Chromatographic separation accomplished isocratically on Acquity UPLC BEH C18 (50 mm Ã—2.1 mm, particle size 1.7 Âµm) and detection utilizing photodiode array detector at 254 nm. Injection volume was 2.0 Âµl.
Results: The calibration curve was linear over the wide concentration range of 6.0Âµg/ml to 54.0Âµg/ml and 20.0Âµg/ml to 180.0Âµg/ml for Tolperisone HCl and Paracetamol, respectively. The retention time of Tolperisone HCl and Paracetamol was 1.396 and 2.625 min, respectively and the total analysis time was 5.0 min. Based on the results, the validated method was effectively applied for the estimation of Tolperisone HCl and Paracetamol in combined dosage form and in single pharmaceutical formulations with a new generation instrument, ultra performance liquid chromatography (UPLC). Moreover, the method helps to get better quality control and to pledge therapeutic efficacy.
Conclusion: The method is simple, less time consuming and comparatively cost effective than existing methods.
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