Validated TLC Densitometric method for the quantification of Cefixime Trihydrate and Ornidazole in bulk drug and in tablet dosage form

A simple, rapid, accurate and precise densitometric method for determination of cefixime trihydrate and ornidazole in combined tablet dosage forms has been developed and validated. The separation was achieved on Merck TLC aluminium sheets of silica gel 60 F254 with nbutanol- methanol-toluene-ammonia 5:2:1:5 (v/v/v/v) as mobile phase. Densitometric quantification was perfomed at 287nm by reflectance scanning. The RF value of cefixime trihydrate (CEF) and ornidazole (ORZ) were found to be 0.51±0.02, 0.36±0.02 respectively. The method was validated with respect to linearity, precision, accuracy, specificity, robustness and ruggedness, in accordance with ICH guidelines. The calibration curve was linear in the concentration range 360-840ng perband for cefixime trihydrate and 900-2100ng perband for ornidazole. For cefixime trihydrate, the recovery studies results ranged from 99.81-100.25% with RSD values ranged from 0.321-0.721%. For ornidazole, the recovery studies results ranged from 99.21-100.12% with RSD values ranged from 0.260-0.841%. The method proved to be a rapid and cost-effective quality control tool for routine simultaneous analysis of cefixime trihydrate and ornidazole in the bulk drug and in a tablet dosage formulation.