HPTLC Method Validation for Simultaneous Determination of Tamsulosin Hydrochloride and Finasteride in Bulk and Pharmaceutical Dosage Form

A reverse phase high performance liquid chromatographic (RP HPLC) method was developed and validated for determining Finasteride and Tamsulosin in bulk and tablet forms. The method demonstrated that tablet excipients did not interfere with drug quantification. The HPLC used a Shimadzu system with a hypersil ODS C18 column and a mobile phase of acetonitrile and KH2PO4 buffer. Detection occurred at 240 nm, with linearity ranges of 125-625 mg/ml for Finasteride and 10-50 mg/ml for Tamsulosin. The method showed adequate sensitivity, reproducibility, and specificity, with satisfactory accuracy and precision, achieving recovery rates of 100.76% for Finasteride and 99.06% for Tamsulosin.

The study developed and validated simple, accurate, and sensitive ultraviolet spectrophotometric and stability indicating reversed phase high performance liquid chromatographic (RP-HPLC) methods for the simultaneous estimation of Tamsulosin and Finasteride in combined tablet dosage forms. The spectroscopic method used an absorbance correction method at 228 and 246 nm, with methanol as the solvent, and adhered to Beer's law for Tamsulosin and Finasteride in specific concentration ranges. The RP-HPLC method utilized a Waters Symmetry C18 column with a methanol, water, and THF mobile phase, and quantification was achieved using a PDA detector at 275 nm. Both methods were successfully applied to pharmaceutical formulations and validated statistically and through recovery studies.