Monday , 24 February 2020

RP HPLC Method Development and Validation of Imipenem and Cilastatin in Bulk and Pharmaceutical Dosage Forms

K. Satyanarayana1, P Sowjanya2, Dr. G. Vijay kumar3*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
3Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A  B  S  T  R A C T
A new method was established for simultaneous estimation of Imipenem and Cilastatin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Imipenem and Cilastatin by using Zodiac silRP C18 4.6×250mm 3.0µm, flow rate was 1.0ml/min, mobile phase ratio was ACN: pH 3 buffer (70: 30 % v/v) (KH2PO4and K2HPO4)  pH 3 (pH was adjusted with orthophosphoric acid), 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 % purity of Imipenem and Cilastatin was found to be 100.27% and 99.87% respectively.The system suitability parameters for Imipenem and Cilastatin such as theoretical plates and tailing factor were found to be 2885, 1.25 and 2235 and 1.33, the resolution was found to be3.48. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Imipenem and Cilastatin was found in concentration range of 50µg-250µg and 5µg-50µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was 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. Hence the suggested RP-HPLC method can be used for routine analysis of Imipenem and Cilastatinin API and Pharmaceutical dosage form.
Keywords: Zodiac silRP C18 column, Imipenem and Cilastatin, HPLC method

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