A simple, precise, accurate, reproducible and economical stability-indicating reverse phase liquid chromatography method is developed and validated for the quantitative simultaneous estimation of flucloxacillin (fluc) and ampicillin (amp) in combined pharmaceutical dosage form. A chromatographic separation of the two drugs was achieved with a thermosil C18 (4.6 x 250 mm, 5 m) analytical column using buffer – sodium phosphate buffer pH (4.5): methanol (60:40% v/v) in isocratic mode at a flow rate of 1.2 ml/min and column at ambient temperature. The detection was monitored at 238 nm using a PDA detector. The stressed samples were analyzed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The described method shows excellent linearity over a range of 10-50 μg/ml for both the drugs. The correlation coefficient for both drugs was 0.9999. The mean recovery values for fluc and amp were 100.22 and 100.83 respectively. The limit of detection for fluc and amp were 0.012 and 0.006 μg/ml respectively. The limit of quantification was 0.042 and 0.020 μg/ml, respectively. The robustness study and percentage of assay of the formulation were found within limit as per ICH guidelines.
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