A Novel Method for the Simultaneous Estimation of Imipenem and Cilastatin by Using RP-HPLC in its Bulk and Pharmaceutical Dosage Form

Satheesh thotla*, R. Vasanthi, Dr. Alagar Raja.M, K.N.V Rao, Devid Banji
Departmernt of Pharmaceutical Analysis, Nalanda College of Pharmacy, Nalgonda, 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 Symmetry C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) Acetonitrile : phosphate buffer (KH₂PO₄and K₂HPO₄)  pH 3 ( pH was adjusted with ortho-phosphoric 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 retention times were found to be 2.449 mins and 3.191 mins. 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 2438, 1.26 and 2235 and 1.33, the resolution was found to be 8.67. The linearity study of 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%.
Keywords: Imepenam, Cilastatin, HPLC, Validation studies