Determination of dutasteride for analytical method development and validation in bulk as well as in pharmaceutical dosage form by using RP-HPLC
Keywords:Dutasteride, ICH Guidelines, HPLC
Objective: The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines.
Methods: The proposed method was simple, fast, accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Reversed-phase high-performance liquid chromatography (RP-HPLC) methods was developed and validated for simultaneous estimation of Dutasteride in bulk drug and in combined dosage forms. RP-HPLC separation was achieved on a Symmetry C18 (4.6 x 250 mm, 5μm, Make: XTerra) under an Isocratic Mode. The mobile phase was composed of Phosphate Buffer (40%) whose pH was adjusted to 3.0 by using Orthophosporic Acid & Acetonitrile (80%) [HPLC Grade]. The flow rate was monitored at 1.0 ml per min. The wavelength was selected for the detection was 280 nm. The run time was 8 min.
Results: The retention time found for the drugs Dutasteride were about 2.2 min. The linearity was established in the range of 20 to 150 µg/ml. The proposed method was adequate sensitive, reproducible, and specific for the determination of Dutasteride in bulk as well as in pharmaceutical dosage form. The validation of method was carried out utilizing ICH-guidelines. The described RP-HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. In the research the proposed method was found to be suitable and accurate for the Quantitative determination of the drug in pharmaceutical dosage form.
Conclusion: The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Dutasteride and Tamsulosin hydrochloride in bulk drug and in combined dosage forms by using the above said chromatographic conditions.
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