ABSTRACT:
A simple, accurate, precise and rapid high-performance thin-layer chromatographic method for determination of Cefixime Trihydrate and Dicloxacillin Sodium in Bulk and combined pharmaceutical dosage form was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase and Toluene : Methanol : Triethylamine (4:6:0.7) as mobile phase. Densitometric analysis was carried out at 229 nm. The system was found to give compact spots for Cefixime Trihydrate and Dicloxacillin Sodium at Rf of 0.58 ± 0.03 and 0.80 ± 0.03 respectively. The linear regression analysis data showed good linear relationship in the concentration range of 200-1600 ng/band and 500-4000 ng/band for Cefixime Trihydrate and Dicloxacillin Sodium respectively. Percent Recovery for Cefixime Trihydrate was 100.75-101.25 and that for Dicloxacillin was 100-101.51. Method was found to be reproducible with % relative standard deviation (%R.S.D) for intra and interday precision <1.5% over the said concentration range. The limits of quantitation for Cefixime Trihydrate and Dicloxacillin Sodium were 21.87ng/band and 27.75ng/band respectively. The suitability of this method for quantitative determination of these compounds was proved by validation in accordance with the requirements of international conference on harmonization ICH, Q2 (R1). The method was found to be precise, accurate and can further be used for routine analysis of these drugs in bulk and in a formulation. The method has been successfully applied in the analysis of combined tablet dosage form.