Validated HPTLC Method for Determination of Cefixime Trihydrate and Erdosteine in Bulk and combined Pharmaceutical Dosage Form
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Department of Quality Assurance, AISSMS College of Pharmacy, Near R.T.O, Kennedy Road, Pune-411001, India
Madhura V. Dhoka   

Department of Quality Assurance, AISSMS College of Pharmacy, Near R.T.O, Kennedy Road, Pune-411001, India
Publication date: 2017-10-25
Eurasian J Anal Chem 2013;8(2):99–106
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.
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