Development and Validation of an RP-HPLC-UV Method for the Analysis of Drugs Used for Benign Prostatic Hyperplasia in Pharmaceutical Preparations

Document Type : Original Article

Authors

1 Department of Quality Assurance, Pioneer Pharmacy Degree College, Vadodara 390019, Gujarat, India.

2 Department of Pharmaceutical Microbiology and biotechnology, Pioneer Pharmacy Degree College, Vadodara -390019, Gujarat, India.

10.18576/jpac/030202

Abstract

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) with UV detection method for the simultaneous estimation of alfuzocin hydrochloride and finasteride in tablets which are used in benign prostatic hyperplasia therapy. The separation and quantification was achieved by Shim pack XR ODS (250 mm x 4.6 mm, 5 μm id) in isocratic mode, with mobile phase consisting of acetonitrile: water with 1 % Triethyl amine (TEA) (pH 7.0) (75:25 v/v) at a flow rate of 1 ml/min. Spectrophotometric detection was performed at a wavelength of 223 nm. The retention time of alfuzocin hydrochloride and finasteride was found to be 2.90 and 4.46 min, respectively. The developed method was validated according to ICH guidelines Q2 (R1). The method was validated for linearity, accuracy, and precision. Linearity for alfuzocin hydrochloride and finasteride were in the range 4-12 μg/ml for both drugs. The relative standard deviation values for intermediate precision studies were <1%. Statistical analysis of the data showed that the method was precise, accurate, reproducible and selective for the analysis of alfuzocin hydrochloride and finasteride. The method was successfully employed for the determination of alfuzocin hydrochloride and finasteride in commercially available tablet dosage form.

Keywords

Journal of Pharmaceutical and Applied Chemistry
Volume 2, Issue 1
January 2016
Pages 47-52

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