Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF REVERSE PHASE ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY FOR THE SIMULTANEOUS DETERMINATION OF TAMSULOSIN HCL AND FINASTERIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

K. Kirubakaran*, M. Bakyalakshmi, P. D. Gokulan, K. L. Senthil Kumar and M. Kalaichandar

ABSTRACT

The study aimed to develop and validate a novel reverse phase Ultra Performance Liquid Chromatography (UPLC) method for the simultaneous estimation of Tamsulosin Hcl and Finasteride in both bulk and pharmaceutical dosage forms. This innovative approach in quality control laboratories utilizes various mobile phase compositions and introduces a new perspective to the market. For enhanced accuracy, a buffer was incorporated into the method. Chromatographic separation of the drugs was accomplished using a Thermo Scientific C18 column (50 X 2.1 mm, 1.9 μm) with a mobile phase of Buffer: ACN (70:30) at pH 2.0 and a flow rate of 0.3 ml/min. Detection of the eluted drugs occurred at 220 nm, revealing retention times of 2.7 and 3.6 minutes for Tamsulosin Hcl and Finasteride, respectively. Thecalibration curve exhibited linearity within the range of 80-120%, with correlation coefficients of 0.999 for both Tamsulosin Hcl and Finasteride. Limits of detection and quantification were determined as 0.24 μg/ml and 0.75 μg/ml for Tamsulosin Hcl, and 0.47 μg/ml and 1.42 μg/ml for Finasteride, all falling within the acceptable range. Method performance was validated in accordance with International Council for Harmonization guidelines, confirming its simplicity, precision, accuracy, and compliance with regulatory standards.

Keywords: Reverse Phase Ultra Performance Liquid Chromatography, Method development, validation, Tamsulosin Hcl, Finasteride.