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).
