Abstract

ESTIMATION OF TAPENTADOL IN BULK AND PHARMACEUTICAL FORMULATION BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC) AND UVSPECTROPHOTOMETRY

Usharani G, Chandra Shekar B, Devanna Nayakanti

Abstract

Tapentadol is an analgesic drug. A RP-HPLC and an UV spectrophotometric assay method were developed and validated for quantitative determination of Tapentadol in pharmaceutical solid dosage form. The chromatography was carried out on a C-18 (250 mm x 4.6 mm, 5 μm) column with Dipotassiumphosphate buffer and acetonitrile (50:50 v/v) as mobile phase at 241 nm detector wave length. The UV method was performed at 241 nm using water as solvent. The linearity was established in the range of 200 to 600μg/ml and 2.5 to 15μg/ml for HPLC and UV methods respectively. The HPLC method was accurate and precise for all the dosage forms studied with a recovery of 98 to 102%. The UV method correlated well with HPLC for the analysis of Tapentadole in tablet dosage form. The proposed method was successfully applied for the reliable quantification of active pharmaceuticals present in the commercial formulations. A good agreement was observed between HPLC and UV methods. The validated HPLC and UV methods can be used for the drug analysis in routine quality control for bulk and dosage forms.

Keywords: Tapentadol, HPLC, Spectrophotometry, analysis.