Volume : 13, Issue : 04, April – 2026
Title:
METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE BY RP-HPLC METHOD IN PHARMACEUTICAL DOSAGE FORM
Authors :
Dr G. Nagaraju*, M. Naga Narasimham*, Dr.N. Ramarao
Abstract :
Background: A simple, rapid, precise, sensitive, and reproducible analytical method was developed for the quantitative estimation of Tamsulosin Hydrochloride and Dutasteride in pharmaceutical dosage forms using Reverse Phase High Performance Liquid Chromatography (RP-HPLC).
Method: Chromatographic separation of Tamsulosin HCl and Dutasteride was achieved using a Waters Alliance e2695 HPLC system equipped with a Luna Phenyl Hexyl column (250 × 4.6 mm, 5 µm). The mobile phase consisted of Acetonitrile and 0.1% TEA (pH 2.5 adjusted with OPA) in the ratio of 20:80 % v/v. The flow rate was maintained at 1.0 mL/min, and detection was performed at 257 nm using a photodiode array (PDA) detector under ambient temperature conditions.
Results: The chromatographic method showed good separation with acceptable system suitability parameters. The number of theoretical plates for both drugs was not less than 2000, and the tailing factor was less than 2, indicating efficient column performance. The percentage relative standard deviation (%RSD) of peak areas was found to be less than 2.0%, demonstrating good precision and repeatability of the method.Validation: The developed method was validated according to the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The validation parameters such as accuracy, precision, specificity, linearity, and robustness confirmed that the method is reliable and suitable for quantitative analysis.
Conclusion: The developed RP-HPLC method was found to be simple, economical, accurate, precise, and robust. Therefore, the method can be effectively used for routine quantitative analysis and stability studies of Tamsulosin Hydrochloride and Dutasteride in pharmaceutical dosage forms.
Keywords: RP-HPLC, Tamsulosin HCl, Dutasteride, Method validation, Stability indicating method.
Cite This Article:
Please cite this article in press M. Naga Narasimham et al., Method Development And Validation For Simultaneous Estimation Of Dutasteride And Tamsulosin Hydrochloride By Rp-Hplc Method In Pharmaceutical Dosage Form, Indo Am. J. P. Sci, 2026; 13(04).
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