European Journal of Biomedical and Pharmaceutical Sciences

STABILITY INDICATING UPLC METHOD OPTIMISATION AND VALIDATION OF PHOLCODINE IN BULK DOSAGE FORM

Anas Rasheed* and Dr. Osman Ahmed

ABSTRACT

A selective, precise, accurate and stability indicating UPLC method is validated for estimation of Pholcodine in bulk 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 1 M KH₂PO₄-acetonitrile in the ratio of 80:20%v/v. The flow rate was 1ml/min and effluent was monitored at 275nm. Retention time was found to be 2.022±0.10 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 8- 40μg/ml respectively. The LOD and LOQ values for were found to be 0.8379(μg/ml) and 2.53918(μg/ml) respectively. The proposed method was successfully used for estimation of Pholcodine in bulk dosage form.

Keywords: Pholcodine, UPLC, Validation, stability indicating method.