DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS DETERMINATION OF MINOXIDIL AND FINASTERIDE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

摘要

A simple, precise, rapid, accurate RP-HPLC method has been developed and validated for the simultaneous determination of Minoxidil and Finasteride in pharmaceutical dosage form. The chromatographic separation was achieved on ODS C₁₈ column (25 cm × 4.6 mm, 5 μ particle size) using a mobile phase comprising methanol: water along with 0.5 % triethyl amine (TEA), pH 6.38 adjusted with ortho phosphoric acid (OPA) in a ratio of 70:30 v/v. The flow rate was 1ml/min and eluents were detected by UV detector at 210 nm. Retention times were found to be 4.661 min and 10.005 min of Finasteride and Minoxidil respectively. The calibration curve was linear over the range of 12-24 μg/ml of Minoxidil and 0.4-0.8 μg/ml of Finasteride. The results of all the validation parameters were well within their acceptance values. The developed method was successfully applied for determination of the two drugs from its pharmaceutical formulation. The excipients in the formulation do not pose any hindrance in determination of the two drugs. The proposed method is suitable for routine quality control analysis.