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

Abstract

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 aluminium plates precoated with
silica gel 60F254 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 Rf 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-1 and 150-750 ng band-1 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 <1.5% over the said concentration range. The limits of
quantitation for Cefixime Trihydrate and Erdosteine were 11.14 ng band-1 and 15.63 ng band-1
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.