The objective of the current study was to develop and validate a rapid, precise, specific and stability-indicating reverse phase HPLC for the quantitative determination of olsalazine in its dosage form. The determination is done for the active pharmaceutical ingredient in its pharmaceutical dosage form in the presence of degradation products. The drug was subjected to stress conditions of acid, alkali, thermal, photolytic, humidity and peroxide. As per international conference on harmonization (ICH) prescribed stress conditions to show the stability-indicating power of the method. It was found olsalazine is very sensitive to various stress conditions. The chromatographic conditions were optimized using the samples generated from forced degradation studies. Regression analysis shows an r value (correlation coefficient) 0.99 for olsalazine. The chromatographic separation was achieved on a symmetry Hypersil BDS C18V 4.6 mm x 150 mm, 5 µm. The method employed an isocratic elution and the detection wave-length was set at 290 nm. The mobile phases consists of ACN:Potassium dihydrogen phosphate in 1000 ml water. (Buffer) pH 6.0 delivered at a flow rate of 1.0 ml per min. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision and robustness.
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