::INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES::

CODEN : IAJPBB
issn 2349-7750

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TITLE:

THE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF IMIPENEM & CILASTATIN BY USING RP- HPLC

AUTHORS:

G. Regena Angel*, S. Bhagyalata, Chaitanya Bangari , Dr. M. B. Venkatapati Raju

ABSTRACT:

A new method was recognized for simultaneous estimation of Imipenem and cilastatin by RP-HPLC method. The chromatographic circumstances were effectively developed for the separation of Imipenem and cilastatin by using SYMMETRYC18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: phosphate buffer(KH2PO4and K2HPO4) pH 3 ( pH was adjusted with orthophosphoric acid),detection wavelength was 258nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times was found to be 3.345 mins and 2.523 mins. The percentage purity of Imipenem and cilastatin was initiate to be 100.27% and 99.87% correspondingly. The system suitability parameters for Imipenem and cilastatin such as theoretical plates and tailing factor was found to be 2885, 1.25 and 2235 and 1.33, the resolution were found to be3.48. The analytical technique was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Imipenem and cilastatin were found in concentration range of 50µg-250µg and 5µg-50µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery were found to be 99.56% and 99.48%, %RSD for repeatability was 1.2 and 2, % RSD for intermediate precision was 1.1 and 1.1 respectively. The precision study was precise, robust, and repeatable.LOD value was 0.03 and 2.17,and LOQ value was 0.11 and 6.6 respectively. Keywords: Imipenem , cilastatin , precise, robust, and repeatable.