Development and Validation of an Assay for Orphenadrine Citrate and Acetaminophen in Besodol Tablet

Abstract

At the present work a simple, precise, accurate and economical reverse phase HPLC with UV detector method, was developed and validated for the simultaneous determination of acetaminophen and orphenadrine citrate in pharmaceutical formulations. better separation was achieved using cyanide column (250mm × 4.6mm, 5μm), maintained at 25 ͦC. The mobile phase was composed of (tri ethyl amine aqueous, methanol and acetonitrile) in the ratio of 50:20:30 (v/v/v), adjusted at pH 3.8 by ortho phosphoric acid. isocratic elution was used with a flow rate of 1.5 ml/min, injection volume was 10μ, and effluents were monitored by UV (220nm). The retention time of acetaminophen and orphenadrine citrate was 2.25 min and 5.9 min, respectively. The method was tested for linearity over a concentration range of (25- 200)% and (25-200)% , for acetaminophen and orphenadrine citrate, respectively, the correlation coefficient (R2), was found to be 0.9988 and 0.9968, respectively. The method successfully passed all validation tests stipulated in the validation protocol of International Conference on Harmonization (ICH) and united State Pharmacopeia (USP).