Method Development and Validation for Rapid Simultaneous Estimation of Tinidazole and Diloxanide Furoate in Pharmaceutical Dosage Form by Using RP-HPLC

Abstract

A new method was established for simultaneous estimation of Tinidazole and Diloxanide furoate by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tinidazole and Diloxanide furoate by using Thermosil RP C18 (4.5×100 mm) 5.0µm, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol. The retention times were found to be 2.408mins and 3.016mins. The % purity of Tinidazole and Diloxanide furoate was found to be 99.24% and 101.27% respectively. The system suitability parameters for Tinidazole and Diloxanide furoate such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study  Tinidazole and Diloxanide furoate was found in concentration range of 50ppm-250ppm and 5ppm-25ppm and correlation coefficient (r²) was found to be 0.999 and 0.999, % recovery was found to be 100.56% and 101.47%, %RSD for repeatability was 0.1 and 0.3, % RSD for intermediate precision was 0.19 and 0.57respectively. The precision study was precise, robust, and repeatable. LOD value was 4.27 and 6.80, and LOQ value was 0.0272 and 0.3125 respectively.