ANALYTICAL STABILITY INDICATING UPLC ASSAY AND VALIDATION USING C18 COLUMN FOR FLUOROMETHOLONE IN PARENTERAL DOSAGE FORM
Journal Title: World Journal of Pharmaceutical and life sciences - Year 2018, Vol 4, Issue 8
Abstract
A pecific, precise, accurate and stability indicating UPLC method is validated for estimation of Fluorometholone in parenteral inhaler dosage form. The method employed, with C18 column (250 ×4.6 mm id)—ACE Generix in gradient mode, with mobile phase of Methanol–water (62 : 38 v/v). The flow rate was 1.5 ml/min and effluent was monitored at 240nm. Retention time was found to be 5.215±0.005 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 0.3245 (μg/ml) and 0.983 (μg/ml) respectively. No chromatographic interference from excipients and degradants were found. The proposed method was successfully used for estimation of Fluorometholone in parenteral dosage form.
Authors and Affiliations
Mohd Shafi
Keywords
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