Validated HPTLC Method for Determination of Cefixime Trihydrate and Erdosteine in Bulk and combined Pharmaceutical Dosage Form.

A simple, accurate, precise and rapid high-performance thin-layer chromatographic method for determination of Cefixime Trihydrate and Erdosteine in Bulk and combined Pharmaceutical Dosage Form was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60F 254 as the stationary phase. The solvent system consisted of Ethyl Acetate: Acetone: Methanol: Water (7.5:2.5:2.5:1.5) as mobile phase. Densitometric analysis was carried out at 235 nm. The system was found to give compact spots for Cefixime Trihydrate and Erdosteine at R f of 0.35 ± 0.05 and 0.56 ± 0.05 respectively. The linear regression analysis data showed good linear relationship in the concentration range 100-500 ng/band and 150-750 ng/band for Cefixime Trihydrate and Erdosteine respectively. Percent Recovery for Cefixime Trihydrate was 99.47-101.85 and that for Erdosteine was 98.99-101.51. Method was found to be reproducible with % relative standard deviation (R.S.D) for intra and interday precision to be 11.14ng/band and 15.63ng/band respectively. The method was validated for precision, accuracy, specificity and robustness. The method has been successfully applied in the analysis of combined capsule dosage form.