ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CODEINE IN SYRUP DOSAGE FORM USING UPLC TECHNOLOGY
Journal Title: World Journal of Pharmaceutical and life sciences - Year 2017, Vol 3, Issue 5
Abstract
A specific, precise, accurate ultra-pressure liquid chromatography (UPLC) method is developed for estimation of Codeine in bulk drug and syrup dosage form. The method employed, with Hypersil BDS C18 (100 mm x 2.1 mm, 1.7 μm) in a gradient mode, with mobile phase of Acetonitrile, methanol, and 1% triethylamine and Buffer solution in the ratio 70: 15: 15 %v/v/v. The flow rate was 1.5 ml/min and effluent was monitored at 210 nm. Retention time was found to be 3.416±0.020 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- 100 μg/ml respectively. The LOD and LOQ values for were found to be 2.093(μg/ml) and 6.3437(μg/ml) respectively. No chromatographic interference from syrup excipients and degradants were found. The proposed method was successfully used for estimation of Codeine in syrup dosage form.
Authors and Affiliations
Anas Rasheed
Keywords
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