A Quantitative Estimation of Piperacillin and Tazobactam in Generic and Branded Pharmaceutical Formulations by Reverse Phase High Performance Liquid Chromatography

Abstract

Background: In India the incidence of sub-standard drugs has risen from 0.04% to 2.3% in 2012 as per Drug Controller General of India (DCGI). There are 66 substandard drugs found in Jammu and Kashmir (India), as per Drugs and food control organization, Jammu and Kashmir 2013. Looking at the rising incidences of sub-standard drugs in the local market of our state, we have chosen piperacillin and tazobactam, used extensively in tertiary care hospital, to verify quality and quantity by employing High Performance Liquid Chromatography (HPLC) based analytical technique

Methods: Chromatographic separation of the two drugs was achieved using analytical column C18 250/4.6 mm, 5µm particle size, 20 µL sample loop size. The mobile phase consisted of a mixture of acetonitrile, methanol and 1% orthophosphoric acid (50:30:20). The drugs were analyzed using UV detector (Diode array detector, DAD) at wavelength 226 nm. The flow rate was maintained at 0.5 mL/min. Column temperature was at 25⁰C by in built column thermostat. The injection volume was 20 µL, with a run time of 8 minutes.

Results and conclusion: Amongst the six formulations (Tazar, Tazomac, Zosyn, Durataz, Jan Aushadhi and Jammu and Kashmir Medical Supplies Corporation Limited, i.e., JKMSCL), all the formulations contained piperacillin within the standards specified by the Indian Pharmacopoeia (94-115%), except JKMSCL, which had slightly higher concentration. Further, tazobactam was present in all the formulations. However, the standards for comparison of tazobactam have not been specified within the Indian Pharmacopoeia.