Development and Validation of a HPLC Method for Imipenem and Meropenem in Pharmaceutical Dosage Forms

Sanju Srinivas¹, Shalindhar²
1Associate Professor Department of Pharmacy, Ganga Pharmacy College, Nizamabad, Telangana
2Department of Pharmaceutical Analysis, Ganga Pharmacy College, Nizamabad, Telangana

Abstract
A new method was established for simultaneous estimation of Imipenem and Meropenem by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Imipenem and Meropenem by using Zodiac sil C18 column (4.6×150mm)5µ , flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: phosphate buffer(KH2PO4and K2HPO4) phosphate pH 3 ( pH was adjusted with orthophosphoricacid),detection wavelength was 240nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.170 mins and 7.025 mins. The % purity of Imipenem and Meropenem was found to be 99.1% and 98.2% respectively. The system suitability parameters for Imipenem and Meropenem such as theoretical plates and tailing factor were found to be 12294, 1.27 and 10491 and 1.03, the resolution  was  found  to  be  8.67.  The  analytical  method  was  validated according  to  ICH guidelines (ICH, Q2 (R1)). The linearity study of Imipenem and Meropenem was found in concentration range of 16µ g-80µ g and 25µ g-125µ g and correlation coefficient (r2) was found to be 0.999 and 0.998, % recovery was found to be 101.7% and 102.0%, %RSD for repeatability was 0.8and 0.5, % RSD for intermediate precision was 1.99 and 1.82 respectively. The precision study was precision, robustness and repeatabilty. LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively .This is method also passes the stability .Hence the suggested RP-HPLC method can be used for routine analysis of Imipenem and Meropenem in API and Pharmaceutical dosage form.
Keywords: Imipenem and Meropenem, Zodiac sil C18 column, RP-HPLC