This study describes the development and validation of stability indicating HPLC method for blonanserin in its bulk and tablet dosage forms. Blonanserin was subjected to different stress conditions such as acid, base, oxidation, dry heat and photolytic stress conditions and the stressed samples were analyzed by the proposed method. Chromatographic separation achieved isocratically on a C18 column by utilizing mobile phase acetonitrile: methanol: water: triethylamine (60 : 30 : 10 : 0.1 v/v/v) at the flow rate of 1 ml/min with UV detection at 240 nm. The retention time of blonanserin is 11-12 min. Linearity was established for blonanserin within the range of 2-12 µg/ml with regression coefficient R2 = 0.999.The limit of detection and limit quantification were found to be 0.053448 μg/ml and 0.161962 μg/ml respectively, percentage recoveries were obtained in the range of 99.58 - 100.98%. The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation and robustness. The method proved to be specific to the drug and its degradation products. All the results were found to be within the specification limit. The method was validated as per ICH guidelines. The developed method can be applied effectively and successfully for determination of blonanserin in bulk and tablet dosage forms and their force degradation studies.
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