Development and validation of a RPHPLC method for determination of residual Tamsulosin hydrochloride on stainless steel surface of pharmaceutical manufacturing equipments

Tamsulosin hydrochloride is clinically important drug as far as benign prostatic hyperplasia is concerned [1, 2]. Cleaning validation is designed to demonstrate the effectiveness of cleaning procedure to remove residue of active drug substances, cleaning agents and microbial attributes to predetermined level. In this work a simple, sensitive, rapid and accurate RPHPLC method with UV detector has been developed and validated for determination of Tamsulosin hydrochloride residues on the surface of manufacturing equipment. We used C18 column (4.6*150 mm, 5 µm) under an isocratic mode. The mobile phase was composed of perchlorate buffer and appropriative organic solvent. The wavelength was selected 225nm. Parameters such as organic solvent, ratio of organic solvent, flow rate and pH of mobile phase were optimized by using Stat-Ease design expert method. Under optimized method LOD and LOQ 0.05 and 0.1 mg/ml were found respectively and the repeatability of the method expressed as relative standard deviation was 0.14%. This method was applied successfully to the analysis of residual Tamsulosin hydrochloride in Rinse and Swab samples of sterile production line equipment.