VALIDATION OF A UPLC METHOD WITH DIODE ARRAY DETECTION USING C-18 COLUMN FOR THE DETERMINATION OF FLUOROMETHOLONE IN PARENTERAL DOSAGE FORM

A selective, precise, accurate UPLC method is validated for estimation of Fluorometholone in parenteral dosage form. The method employed, with C18 column (250 x4.6 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 5.05 +/- 0.03 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 mu g/ml respectively. The LOD and LOQ values for were found to be 0.3245 (mu g/ml) and 0.983 (mu g/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.