Journal of Harmonized Research in Pharmacy

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF OFLOXACIN AND OMEPRAZOLE IN BULK DRUG

Abstract

Author(s): Sarmita Rania, Manish Majumder, Amit Sharma, Amit Rai, Durgadas Anghore

Ofloxacin (OFL) and Omeprazole (OMP) are synthetic drugs active against H. Pylori. UV-Spectrophotometric analytical method was validated to assay Ofloxacin and Omeprazole in tablet. Measurements were taken at 298 and 302 nm using methanol and water as solvent. This new method was developed and validated in accordance with ICH requirements, which include linearity, precision, accuracy, specificity, detection and quantitation limits. The simultaneous estimation method demonstrated good linearity over the range of 5-30 µg/mL. The mean percentage recoveries were 101.11, 100.86 of OMP and OFL. In Derivative spectroscopy, percentage recovery of OMP and OFL were 101.13, 100.86. In Zero crossing method, values found were 101.73, 101.53 OMP and OFL respectively. The repeatability values were found 0.0045, 0.0053 for OMP, 0.0058 and 0.0054 for OFL in simultaneous method. In first order derivative spectroscopy, values were found 0.0045, 0.0053 for OMP, 0.0058 and 0.0054 for OFL at 225 and 235 nm. In simultaneous estimation method, LOD values were found to be 2.29, 1.56 and LOQ values were 2.86, 2.72 for OFL and OMP respectively, in first order derivatives, LOD values were found to be 2.65 and 2.08. LOQ values were 4.75, 3.92 for OMP and OFL respectively, In Q Analysis method, LOD values were found to be 1.97 and 2.64. LOQ values were 3.32, 3.84 for OMP and OFL respectively. In house Formulation by simultaneous equation method showed that the percentages 101.98, 101.21 and 102.31, 102.01 for OMP and OFL. In first order derivative spectroscopy method, values were 102.31, 102.09 for OMP and 102.12, 101.96 for OFL, In Q-Analysis method, values were found 102.65, 102.41 for OMP and 102.32, 101.78 for OFL. The proposed method might be applied in routine quality control in the pharmaceutical industries since it is precise, accurate, simple, and economic, produces very low amounts of solvents and residues. .Keywords: Simultaneous quantitative determination, UV, HPLC and Ofloxacin and Omeprazole.