ABSTRACT:
Stability-indicating HPLC method of analysis of gatifloxacin sesquihydrate (GS) both as a bulk drug and in pharmaceutical formulations was developed and validated. An isocratic separation was achieved using a µBondapackTM ODS C18 (300 mm X 3.9 mm i.d., 10 µm particle size) column with a flow rate of 0.8 ml/minute and using a UV detector to monitor the eluate at 293 nm. The mobile phase consisted of acetonitrile and sodium acetate buffer pH 3.4 (0.2 % triethylamine was added in buffer and pH of buffer was adjusted to 3.0 with o-phosphoric acid) in the ratio of 25:75 v/v. The drug was subjected to oxidation, hydrolysis, photolysis, dry heat and wet heat to apply stress conditions. The degraded products were well separated from the pure drug. The method was also applicable to quantitative determination of GS in human plasma. The developed method was validated in terms of selectivity, linearity, limit of quantitation, limit of detection, precision, accuracy and recovery. Degradation products resulting from the forced degradation studies did not interfere with the detection of GS and the method is thus stability-indicating