Method development and validation for ciprofloxacin and ornidazole in its bulk and combined dosage forms by RP–HPLC

Abstract

A new method was established for simultaneous estimation of Ciprofloxacin and Ornidazole by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Ciprofloxacin and Ornidazole by using Inertsil C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (30:70%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2. The retention times were found to be 2.399mins and 3.907mins. The % purity of Ciprofloxacin and Ornidazole was found to be 100.7% and 101.4% respectively. The system suitability parameters for Ciprofloxacin and Ornidazole such as theoretical plates and tailing factor were found to be 1.3, 5117.5 and 1.4, 3877.3 the resolution was found to be 8.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Ciprofloxacin and Ornidazole was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.9988 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2 and 0.4, % RSD for intermediate precision was 0.5 and 0.1 respectively. The precision study was precise, robust, and repeatable. LOD value was 2.95 and 3.04, and LOQ value was 9.87 and 10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Ciprofloxacin and Ornidazole in API and Pharmaceutical dosage form.