Original Articles: 2015 Vol: 7 Issue: 6
Development and validation of stability indicating RP-HPLC with UV detection method: Analysis of Dutasteride in pharmaceutical dosage forms
A simple and rapid stability indicating liquid chromatographic method with UV detection was developed and validated for the determination of dutasteride in bulk drug and pharmaceutical dosage form. Chromatographic separation has been achieved within 5 minutes by using an Agilent Zorebax SB Phenyl analytical column (250 mm × 4.6 mm, 5 µm) as the stationary phase with a mobile phase consisted of orthophosphoric and methanol (60:40 v/v) at a flow rate of 1.0 ml/min. Using an UV detector, detection was performed at 248 nm. The method was validated in accordance with International Conference on Harmonization guidelines with respect to linearity, sensitivity, selectivity, accuracy, precision, specificity and robustness. Regression analysis showed good correlations (R 2=0.9994) for dutasteride in the concentration range of 4-60 µg/ml. The dutasteride was exposed to acidic, basic, oxidation, photo degradation and dry heat stress conditions. The developed HPLC method can efficiently separate the dutasteride from its degradation products. Therefore, it can be employed as stability-indicating method. The percentage recovery was in the range of 99.84–100.13% with relative standard deviation in the range of 0.046– 0.076 %, for dutasteride from the pharmaceutical dosage form. The proposed method is suitable for determination of dutasteride in bulk drug and in its pharmaceutical dosage form.