DEVELOPMENT AND VALIDATION OF A SIMPLE UV-SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF CIPROFLOXACIN HCL PRESENT IN TASTE MASKED DRUG RESIN COMPLEX

Abstract

Objective: The objective of this study was to develop and validate a novel, specific, precise and simple UV-spectrophotometric method for the estimation of ciprofloxacin HCl present in taste-masked drug-resin complex.

Methods: UV-spectrophotometric determination was performed with ELICO SL 1500 UV-Vis spectrophotometer using 0.1 N HCl as a medium. The spectrum of the standard solution was run from 200-400 nm range for the determination of absorption maximum (λ max). λ max of ciprofloxacin HCl was found at 276 nm. The absorbance of standard solutions of 1, 2, 3, 4, 5 and 6 µg/ml of drug solution was measured at an absorption maximum at 276 nm against the blank. Then a graph was plotted by taking concentration on X-axis and absorbance on Y-axis which gave a straight line. Validation parameters such as linearity and range, selectivity and specificity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness were evaluated as per ICH guidelines.

Results: Linearity for the UV-spectrophotometric method was noted over a concentration range of 1-6 µg/ml with a correlation coefficient of 0.9995. The limit of detection (LOD) and limit of quantification (LOQ) for ciprofloxacin HCl was found at 0.46 μg/ml and 1.38 μg/ml respectively. Accuracy was in between 98.89 and 99.27%. % RSD for repeatability, intraday precision and interday precision were found to be 1.271, in between 0.351 and 0.659 and in between 1.067 and 1.769 respectively. The proposed UV spectrophotometric method is found to be robust.

Conclusion: The proposed UV-spectrophotometric method was validated according to the ICH guidelines and results and statistical parameters demonstrated that the developed method is sensitive, precise, reliable and simple for the estimation of ciprofloxacin HCl present in taste-masked drug-resin complex.