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TITLE:

THE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND SATRANIDAZOLE BY USING RP- HPLC

AUTHORS:

Vangalapudi Revathi*,Santanu Kumar Hotta, ChaitanyaBangari, Dr.M.B.Venkatapathi Raju

ABSTRACT:

A method was developed on trial & error basis by changing the variables wherever required. Finally a method was optimized and the conditions were determined. Method was developed by using RP HPLC Method During this optimization at every trial a new combination of mobile phase was tried to overcome the drawbacks of the previous run. Finally the method was optimized at trial 5, the optimized method was using 40 volumes of 20mM Phosphate buffer pH 3.0: 60 volumes of Acetonitrile at 305 nm and validated as per ICH guidelines. The method was validated for system suitability, linearity, precision, accuracy, specificity, robustness, LOD and LOQ. The system suitability parameters were within limit, hence it was concluded that the system was suitable to perform the assay. The method shows linearity between the concentration range of 60-140µg / ml for Ofloxacinand 72-168 for Satranidazole. The % recovery of Ofloxacin and Satranidazole were found to be in the range of 98.0 % - 102.0 %. As there was no interference due to mobile phase, the method was found to be specific. The method was robust as observed from insignificant variation in the results of analysis by changes in Flow rate and wavelength variation separately and analysis being performed by different analysts. Keywords: Acetonitrile, Ofloxacin ,Satranidazole, Flow rate and wavelength

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