Abstract
A new simple, accurate, RP-HPLC method and stability indicating test was developed and validated for determination of TAMSULOSIN HYDROCHLORIDE and DUTASTERIDE tablet dosage forms. Chromatographic separation was achieved on a Kromosil C18 column (250×4.6mm×5μ) using mobile phase consisting of a mixture ofAmmonium acetate Buffer:ACN:MeOH (40:30:30v/v) PH 3.5, with detection of 228 nm. Linearity was observed in the range 19.2-44.8 μg /ml for TAMSULOSIN HYDROCHLORIDE (r2 =0.9961) and 24-56μg /ml for DUTASTERIDE (r2 =0.9981).LOD was found to be 0.74 μg/ml (TAM) and 1.29 μg/ml (DUTA) & LOQ was 2.24 μg/ml / ml (TAM) and 3.91 μg/ml (DUTA) respectively. Recovery studies was found to be 100.23 % (TAM) - 99.47% (DUTA) within the range. The method developed was precise, accurate Robust, Rugged showing %RSD NMT 2.00.Then FD studies were conducted for both drugs in RP-HPLC, the results showed that drugs are stable in all stress conditions. Hence all statistical data proves validity of the proposed method and can be used for routine analysis of bulk drug and pharmaceutical dosage form.
