Analytical Method Development and Method Validation of Ofloxacin and Ornidazole by Rp--Hplc in Tablet Dosage form

Pharmaceutical analysis deals not only with medicaments (drugs and formulations), but also with their precursors i.e. with the raw material whose degree of purity, which in turn decides the quality of medicaments. The quality of a drug is determined, after establishing its authenticity, which is carried by testing its purity and the quality of the pure substance in the drug and its formulations. A RP-HPLC method for of olaxacin and ornidazole were developed and validated in tablet dosage form as per ICH guidelines. The results are found to be complying with the acceptance criteria for each of the parameter. Shimadzu HPLC(Autochrome 3000 software with UV detector) with Cosmosil C18 –MS –II (150X 4.6MM, 5μ) Packed Column, Injection volume of 20μl is injected and eluted with the Mobile phase ( Buffer and CAN, in the ratio of 80:20) Which was pumped at a flow rate of 1.0 ml at 308nm.The peak of ofloxacin and ornidazole was found well separated at 3.0min , 6.0min.The developed method was validated for various parameters as per ICH guidelines like system suitability,accuracy,precision, linearity , specificity, limit of detection ,limit of quantitation ,ruggedness,robustness. Hence it is concluded that the assay method is found to be valid in terms of reliability, precision, accuracy and specificity and hence it is suitable for routine anaclysis as well as for stability analysis