Treffer: Pharmaceutical Sciences DEVELOPMENT AND VALIDATION OF A REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE ESTIMATION OF GLIMEPIRIDE IN BULK AND DOSAGE FORMS
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A novel method for the determination of Glimepiride in bulk and in dosage form by RP-HPLC has been developed and validated. This is simple, rapid, precise and accurate method. The method was developed on a cosmosil ODS (250×4.6mm, 5µ) column using ammonium acetate buffer (pH 5.1) and acetonitrile (40:60v/v) as mobile phase which was pumped at a flow rate of 1.0 ml/min and the detection was done at 230 nm. The retention time was found to be 9.05 min. The developed method was validated by performing studies related to linearity, accuracy, precision, specificity and robustness. The linearity was observed in the concentration range of 100-500µg/ml. The results of recovery studies indicated that the method was accurate. Hence the developed method was found to be suitable for the estimation of Glimepiride in bulk and in dosage form. KEY WORDS Glimepiride, RP-HPLC, determination in bulk & dosage forms, linearity.