Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

Abstract

A novel RP-HPLC method for quantification of tapentadol HCl in pharmaceutical formulations

Author(s): Ruhul Kayesh, Md. Sharif Hasan and Md. Zakir Sultan*

A rapid and highly sensitive reversed phase high performance liquid chromatographic method was developed for quantitative estimation of tapentadol hydrochloride in pharmaceutical preparations. The method was validated according to ICH, FDA and USP guidelines with respect to accuracy, precision, specificity, linearity, robustness, sensitivity and system suitability. The method was developed by using an isocratic condition of mobile phase comprising with 60% buffer [potassium di-hydrogen phosphate (0.03 molar) and n-heptane sulphonic acid- Na salt (0.002 molar)] and 40% acetonitrile at a flow rate of 1.0 mL/min over C-18 (ODS, 250 x 4.6 mm) column at ambient temperature. The retention time was found to be at 3.7± 0.1 min. The recovery was found as >90% which demonstrated the accuracy of the protocol. Intraday and inter-day precision studies of the new method were less than the maximum allowable limit (RSD%£ 2.0 according to FDA). The method showed linear response with correlation coefficient (r2) value of 0.999. Therefore, it was found to be accurate, reproducible, sensitive and less time consuming and can be successfully applied for the assay of tapentadol hydrochloride in any pharmaceutical formulations.


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