Application of HPLC and HPTLC for the Simultaneous Determination of Cefixime Trihydrate and Ambroxol Hydrochloride in Pharmaceutical Dosage Form

Abstract

Two sensitive and reproducible methods are described for the quantitative determination for the
simultaneous estimation of cefixime trihydrate and ambroxol hydrochloride. The first method was
based on HPTLC followed by densitometric measurements of their spots at 254 nm. The separation
was on HPTLC aluminium sheets of silica gel 60 F254 using acetonitrile: methanol: triethylamine
(8.2:1:0.8, v/v/v) as mobile phase. The linear regression analysis was used for the regression line in the
range of 200 - 1000 ng spot-1 for cefixime and ambroxol, respectively. This system was found to give
compact spots for cefixime and ambroxol, after development. The second method was based on HPLC
separation of the two drugs on the column [C18 (5 µ, 25 cm×4.6 mm, i.d.)] at ambient temperature
using a mobile phase consisting of acetonitrile: methanol (50:50, v/v). Quantitation was achieved with
UV detection at 254 nm based on peak area with linear calibration curves at concentration ranges 4 -
18 and 4 - 28 μg mL-1 for cefixime and ambroxol, respectively. Both methods have been successively
applied to pharmaceutical formulation. No chromatographic interference from the tablet excipients
was found. Both methods were validated in terms of precision, robustness, recovery and limits of
detection and quantitation.