STABILITY INDICATING UPLC METHOD OPTIMISATION AND VALIDATION OF ACETYLCYSTEINE IN SYRUP DOSAGE FORM
Anas Rasheed* and Dr. Osman Ahmed
A selective, precise, accurate and stability indicating UPLC method is validated for estimation of Acetylcysteine in syrup dosage form. The method employed, with Hypersil BDS C18 (100 mm x 2.1 mm, 1.7 μm) column in gradient mode, with mobile phase of Methanol and Acetonitrile in the ratio of 40:60 %v/v. The flow rate was 1 ml/min and effluent was monitored at 215nm. Retention time was found to be 3.90±0.15 min. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 20- 100μg/ml respectively. The LOD and LOQ values for were found to be 2.10(μg/ml) and 6.3643(μg/ml) respectively. No chromatographic interference from syrup’s excipients and degradants were found. The proposed method was successfully used for estimation of Acetylcysteine in syrup dosage form.
Keywords: Acetylcysteine, UPLC, Validation, stability indicating method.
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