VALIDATION OF A FORCED DEGRADATION UPLC METHOD USING C8 COLUMN FOR FLUOROMETHOLONE IN PARENTERAL DOSAGE FORM

Mohd Shafi*, Dr. Osman Ahmed and Dr. Anas Rasheed

ABSTRACT

A specific, precise, accurate and stability indicating UPLC method is validated for estimation of Fluorometholone in parenteral dosage form. The method employed, with C8 column (250 ×4.6 mm id)—ACE Generix in gradient mode, with mobile phase of Acetonitrile with buffer 0.5M potassium dihydrogen orthophosphate (35: 65%v/v). The flow rate was 2 ml/min and effluent was monitored at 215nm. Retention time was found to be 5.167±0.015 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 0.3156 (μg/ml) and 0.95662(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.

Keywords: Fluorometholone, UPLC, Validation, parenteral, stability indicating method.