Accurate and Precise RP-HPLC Quantification of Piperacillin and Tazobactum Combination in Dosage Forms: A Quality Control Perspective

Abstract

A simple, precise and accurate reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for the simultaneous estimation of piperacillin and tazobactum in pharmaceutical formulations. Separation was achieved on a C18 column using a mixture of potassium dihydrogen orthophosphate buffer (pH 3.5) and acetonitrile in the ratio of 60:40 v/v as the mobile phase at a flow rate of 1 ml/min. Detection was carried out at 226 nm. The retention times of piperacillin and tazobactum were about 2.5 and 4.3 min respectively. The method was validated as per ICH guidelines with respect to linearity, accuracy, precision, limit of detection, limit of quantification, robustness and ruggedness. The linearity ranges were found to be 5-15 μg/ml and 10-30 μg/ml for piperacillin and tazobactum respectively with correlation coefficients greater than 0.996. Accuracy, expressed as percentage recovery, was within 98-102%. The method also showed good precision and selectivity for the analysis of the drugs. The limits of detection and quantification for both analytes were adequate. In conclusion, the developed method was found to be suitable for the routine quality control analysis of piperacillin and tazobactum in pharmaceutical dosage forms.