European Journal of Biomedical and Pharmaceutical Sciences

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF FLUCONAZOLE AND TINIDAZOLE IN TABLET DOSAGE FORM

Madireddy Mamatha, Nampelly Karnakar, Reddy Sunil* and Anil Middha

ABSTRACT

Pharmaceutical Analysis plays a very significant role in quality control of pharmaceuticals through a rigid check on raw materials used in manufacturing of formulations and on finished products. RP-HPLC method was developed and validated as per ICH guidelines for the estimation of Fluconazole and Tinidazole. Simultaneous Estimation of Fluconazole and Tinidazole were carried out by RP- HPLC using Ortho phosphoric acid buffer (PH 4.0): Methanol (70:30) and column Phenomenex Luna C-18 (250*4.6 mm, 5um) as a stationary phase and peak was observed at 210 nm which was selected as a wavelength for quantitative estimation. After the development of the method, it was validated for specificity, linearity, precision, accuracy, robustness and ruggedness studies. Theoretical plate for Fluconazole was found to be 7040, for Tinidazole it was found to be 7677. From the linearity studies, the specified range for Fluconazole and Tinidazole was found to be 50% to 150%. it was found that recovery value of pure drug were between 99 % to 101% which indicates that the method is accurate and also reveals that commonly used excipients and additives present in the pharmaceutical formulations were not interfering in the proposed methods. The ruggedness of the method was checked by different analysts and found that the results were nearly same which indicates that the method is rugged. Based on the results observed, it was concluded that proposed method can be used for routine analysis of Fluconazole and Tinidazole.

Keywords: Fluconazole, Tinidazole, specificity, linearity, precision, accuracy, robustness and ruggedness.