Development and Validation of HPTLC method for simultaneous Estimation of Ciprofloxacin and Ornidazole in Tablet Dosage Forms

Abstract

A simple, sensitive, precise and accurate HPTLC method has been developed for the simultaneous estimation of the ciprofloxacin and ornidazole in tablets. The stationary phase used was precoated silica gel 60F 254 plate. The mobile phase used was a mixture of n-butanol:ethanol:8M ammonia (5:0.5:1.5, v/v/ v). The densitometric scanning was carried out at 315 nm. This system was found to give compact spots for ciprofloxacin (R f value of 0.25 0.004) and ornidazole (R f value of 0.82 ± 0.007). The method was validated in terms of linearity, accuracy, precision, limit of detection, limit of quantification and specificity in accordance with the ICH guidelines. The calibration curve was found to be linear between 40 to 140 ng/spot for each ciprofloxacin and ornidazole with significantly high value of correlation coefficient (r 2 > 0.99). The limit of detection and quantitation were found to be 10.01 and 33.03 ng/spot, respectively for ciprofloxacin and the limit of detection and quantification were found to be 7.62 and 25.15 ng/spot, respectively for ornidazole. The results of analysis have been validated statistically and by recovery studies. The proposed HPTLC method can be successfully applied in the routine analysis of commercial pharmaceutical tablets.