STABILITY INDICATING UPLC METHOD FOR QUANTIFICATION OF TOLPERISONE HCL AND PARACETAMOL FROM MUSCLE RELAXANT COMBINATION TABLET

  • Madhavi Patel National Facility for Drug Discovery through NCE’s Development & Instrumentation Support to SMPE’s, Department of Chemistry, Saurashtra University, Rajkot 360005, Gujarat, India, 2Department of Chemistry, Banasthali Vidyapith, Banasthali 304022, Rajasthan, India
  • Bhawani Singh Department of Pure & Applied Chemistry, University of Kota, Kota 324005, Rajasthan, India
  • Anamik Shah National Facility for Drug Discovery through NCE’s Development & Instrumentation Support to SMPE’s, Department of Chemistry, Saurashtra University, Rajkot 360005, Gujarat, India

Abstract

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 ºC column temperature. Chromatographic separation accomplished isocratically on Acquity UPLC BEH C18 (50 mm ×2.1 mm, particle size 1.7 µm) and detection utilizing photodiode array detector at 254 nm. Injection volume was 2.0 µl.

Results: The calibration curve was linear over the wide concentration range of 6.0µg/ml to 54.0µg/ml and 20.0µg/ml to 180.0µg/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.

 

Keywords: Simultaneous, Isocratic, Stability indicating, Ultra performance liquid chromatography, Tolperisone HCl, Paracetamol

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How to Cite
Patel, M., B. Singh, and A. Shah. “STABILITY INDICATING UPLC METHOD FOR QUANTIFICATION OF TOLPERISONE HCL AND PARACETAMOL FROM MUSCLE RELAXANT COMBINATION TABLET”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 8, no. 8, June 2015, pp. 299-04, https://innovareacademics.in/journals/index.php/ijpps/article/view/6840.
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