Volume :
3
Issue :
4
Abstract :
Analytical method development being a vital part of preformulation-formulation research and development obviates the need to develop reliable, effective, ecofriendly and cost effective methodologies for routine analysis of active pharmaceutical ingredients. UV spectroscopy is one of the earliest, yet of wide applications in drug analysis in different stages of formulations and quality control; despite the availabilities of sophisticated chromatographic and other hyphenated techniques. Current research attempts to develop simple, sensitive, accurate, precise and economical UV spectrophotometric methods for the simultaneous estimation of alfuzosin (AFZ) and dutasteride (DUT) in bulk and tablet formulations by simultaneous equation method. From the overlain spectra, 247.5 nm and 241 nm were selected as sampling wavelengths for AFZ and DUT respectively. Assay results showed 10.163 mg of AFZ and 0.504 mg of DUT were found in the tablet dosage form. The method was validated as per ICH guidelines. Linearity was obtained in the concentration range of 0.5-5 μg/mL for AFZ and 5-50 μg/mL for DUT. The %RSD for intraday and interday variations of AFZ was found to be 0.422±0.001 and 0.319±0.002 respectively. An intraday and interday variation of DUT was found to be 0.517±0.001 and 0.563±0.001 respectively. In both cases values were within the acceptance limit of < 2%. The mean percentage recovery values for AFZ and DUT were 99.79 % and 100.02% respectively, within the acceptance limit of 98% to 102%. From the high recovery values (> 98 %) it can be inferred that the method is free from the interference of excipients used in the formulation. Based on the results obtained the proposed method can be regarded as simple, accurate, precise, and reliable which can be employed for routine quality control of AFZ and DUT in bulk and combined tablet dosage forms.