| dc.description.abstract | A simple, sensitive, selective and specific, precise and accurate TLC densitometry
method has been developed and validated for simultaneous determination
Theophylline and Ephedrine hydrochloride in tablet dosage form. The method
employed TLC aluminium plates precoated with silica gel 60 F254 as the stationary
phase. The solvent system consisted of ethyl acetate : glacial acetic acid : aquabidest
(11 : 5 : 1 v/v). For detected Ephedrine hydrochloride, the TLC plate must be eluted
again with 0,5% ninhydrin solution in aquabidest and then TLC plate was heated at
105
0
C for 15 min. Quantitative evaluation was performed by measuring the
absorbance-reflectance of the analyte spot at 279 nm for Theophylline and 505 nm
for Ephedrine hydrochloride. The polynomial regression data for the calibration
plots showed good linear relationship with r = 0.99758 in the concentration range of
2000-10000 ppm for Theophylline and the linear regression data for the calibration
plots of Ephedrine hydrochloride showed good linear relationship with r = 0,99689
in the concentration range 200-800 ppm. The minimum detectable amounts were
found to be 68,79 ppm and 35,67 ppm for Theophylline and Ephedrine
hydrochloride, respectively. The limits of quantitation were found to be 206,4 ppm
for Theophylline and 107 ppm for Ephedrine hydrochloride. Repeatability precision,
as RSD was 1,707% for Theophylline and 2,838% for Ephedrine hydrochloride.
Inter-day precision, as RSD was 1,953% and 1,945% for Theophylline and
Ephedrine hydrochloride respectively. Accuracy of the method was determined
through recovery studies by adding known quantities of standard drug to the pre
analyzed test solution and was found to be 100,7% ± 1,953% and 98,23% ± 2,054%.
This TLC Densitometry method is selective and specific, precise, and accurate and
can be used for routine analysis of tablet in industrial quality control laboratories. | en_US |
