ICH guideline practice: application of validated RP-HPLC-DAD method for determination of tapentadol hydrochloride in dosage form

Abstract

Background: Tapentadol is a novel centrally acting analgesic. There is no method for the determination of drug content in dosage form without any interference of any excipients and without using the diethylamine content in the mobile phase with UV detection. Methods: A simple, precise, and accurate new reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated as per International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines to determine tapentadol hydrochloride in tablet dosage form. It was successfully eluted at 5.34 min by mixture of 0.1% formic acid in water and acetonitrile (75:25) on C18 column (250 mm × 4.6 mm, 5 μm) at the flow of 1 ml/min. Results: Drug content was determined in between 99.79% and 100.33% with standard deviation of 0.217 without using dimethylamine with UV detection. Conclusions: The validated RP-HPLC method may be successfully applied for assay, dissolution studies, bio-equivalence studies, as well as routine analysis in pharmaceutical industries.