HPTLC Determination of Amoxicillin Trihydrate and Bromhexine Hydrochloride in Oral Solid Dosage Forms
Journal Title: Journal of Pharmaceutical Sciences and Research - Year 2010, Vol 2, Issue 8
Abstract
A simple, accurate, precise and rapid high-performance thin-layer chromatographic method for determination of Amoxicillin Trihydrate and Bromhexine Hydrochloride in Bulk and combined Pharmaceutical Dosage Form was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of Butyl Acetate: Glacial acetic acid: Methanol: Water (5:2.5:2.5:1) (v/v/v/v) as mobile phase. Densitometric analysis was carried out at 320nm For Amoxicillin Trihydrate and at 260nm for Bromhexine Hydrochloride-260 nm. The system was found to give compact spots for Amoxicillin Trihydrate and Bromhexine Hydrochloride at Rf of 0.51 ± 0.05 and 0.74 ± 0.05 respectively. The linear regression analysis data showed good linear relationship in the concentration range 10-30 (µg/band) and 200-1000 (ng/band) for Amoxicillin Trihydrate and Bromhexine Hydrochloride respectively. Percent Recovery for Amoxicillin Trihydrate was 98.59-101.58 and that for Bromhexine Hydrochloride was 99.14-101.45. 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 Amoxicillin Trihydrate and Bromhexine Hydrochloride were 0.033(µg/band) and 4.51 (ng/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
Authors and Affiliations
M. V. Dhoka , V. T. Gawande , P. P. Joshi
Keywords
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