Research Articles

2017  |  Vol: 2(4)  |  Issue: 4 (July- August)
Development and validation of a Reversed Phase HPLC method for simultaneous determination of Tamsulosin and Dutasteride in tablet dosage form

P. Nagaraju*, B. Durga Prasad, G. Indira Priyadarshini

Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur-522002, Andhra Pradesh, India.

Address for Corresponding Author

P. Nagaraju

Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur-522002, Andhra Pradesh, India.

Abstract

Objective: A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of Tamsulosin and Dutasteride in tablets. Materials and methods: Chromosil C18 column (250 mm x 4.6 mm, 5µ) mixture of Methanol, Acetonitrile and 2% O-phosphoric acid in the ratio of 60:20:20 v/v/v as a mobile phase; at a flow rate of 1.0 mL/min. UV detection was performed at 234 nm. Results: The retention times were 2.19 and 5.19 min for Tamsulosin and Dutasteride respectively. Calibration plots were linear (r2=0.999) over the concentration range of 16-96 µg/mL for Tamsulosin and 20-120 µg/mL for Dutasteride. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. Conclusion: The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Tamsulosin and Dutasteride in bulk and tablet dosage form.

Keywords: Tamsulosin, Dutasteride, RP-HPLC, tablets

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