RP HPLC method for the determination of finasteride andtamsulosin in bulk and pharmaceutical formulations

[摘要] A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Finasteride and Tamsulosin in bulk and tablet dosage forms. It was found that the excipient in the tablet dosage forms does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography on Shimadzu HPLC, 10-At detector with hypersil ODS C18 Column 250 X 4.6 mm (particle size of 5μ) and constant flow pump. Rheodyne injector with 20 μl loop with a mobile phase composed in the ratio acetonitrile: (0.05M) KH2PO4 buffer (45:55) at flow rate 1.8 ml /min. The detection was monitored at 240nm. The linearity range was found between 125-625mg/ml for Finasteride 10-50 mg/ml for Tamsulosin and internal standard (Bromhexine) 40mg/ml were prepared by suitable dilutions of the stock solution with appropriate mobile phase. The interday and intraday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of Finasteride and Tamsulosin in bulk and tablet dosage forms. LOD and LOQ for Finasteride and Tamsulosin were found to be 1.25, 4.166 and 0.495 and1.635.Accuracy (recoveries: finasteride- 100.76% & Tamsulosin 99.06%) and reproducibility was found to be satisfactory.

[学科分类] 药理学