Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF CEFIXIME AND ORNIDAZOLE IN BINARY COMBINATION AND MARKETED FORMULATIONS

Vishal Chudasama*, Megha Patel, Kiran Suthar, Bharat Rajpurohit, Ashok Patel

Abstract

Background: Cefixime is a tird generation cephalosporin antibiotic and Ornidazole is a imidazole derivation antibacterial agent. Both in fixed dose combination is used in management of GIT disorder specially diarrhoea. HPLC is precise and accurate sophisticated instrumentation technique used routinely in analysis of pharmaceuticals and other chemicals. Objective: No HPLC method have been reported for Simultaneous Determination of Cefixime and Ornidazole, hence this study aims to develop and validate a simple high-performance liquid chromatography (HPLC) method for the simultaneous determination of Cefixime and Ornidazole. Method: Isocratic elution was carried out in water and ACN (75:25) with 0.3% Triethyamine, Final pH adjusted to 3.2 ± 0.1 with 10 % o-phosphoric acid. The flow rate was kept 1 mL/min for 10 min and detection wavelength at 310 nm. The method has been validated according to International Conference of Harmonization (ICH) Q2 (R1) guidelines with respect to specificity, system suitability, accuracy, precision, and robustness. The developed method was further used for the determination of CFX and OZ in Marketed formulation. Result: The method was linear in the concentration range of 01-70 mg/mL for Cefixime and Ornidazole. The limit of detection (LOD) and limit of quantification (LOQ) were 0.37 and 1.23 μg mL for cefixime, respectively, while LOD and LOQ for Ornidazole were 0.41 and 1.37 μg/respectively. The percentage recovery that was found to be in the range of 99-102% with relative standard deviation less than 2% indicating the accuracy and precision of method for both the drugs. Further, the validated method was found specific to detect presence of both the drugs in extracts, marketed formulations. Conclusion: The developed method showed excellent specificity, linearity, accuracy and precision. Thus, it can be further explored to detect curcumin and quercetin in bulk powder mixture as well as other marketed formulations.

Keywords: Cefixime, RP-HPLC, Ornidazole, Validation.