Development and Validation of UV Analytical Methods for Quantification in combination of Cilastatin Sodium and Imipenem

Abstract

Cilastatin sodium and imipenem is a well-established broad-spectrum intravenous antibiotic used for the treatment of life-threatening infections worldwide. The present has been studied by various methods by ultraviolet (UV) spectroscopy, although this technique remains one of the simplest, most accurate and precise validated quality control laboratory methods. The aim of this study was to validate a method for separating the intercalating peaks of the UV spectra of imipenem and cilastatin and to compare the purity and quantities of these two active ingredients in different marketed brands. In present study simultaneous equation in UV methods, were developed and validated for some of the selected formulations containing two drug combinations. UV spectroscopic methods solving simultaneous equation is developed and validated for the following drug combination and formulation Cilastatin sodium & Imipenem. In UV spectroscopy all the selected raw materials were dissolved in methanol and their spectra were recorded and the formulations were analysed. The actual number of drugs in formulation was calculated by solving simultaneous equation. As the methods require only methanol as a solvent and less time-consuming process, it can be followed in routine analysis to standardize the raw material as well as finished products with reproducible results.