PENGEMBANGAN DAN VALIDASI METODE KLT DENSITOMETRI UNTUK PENETAPAN KADAR TEOFILIN DAN EFEDRIN HIDROKLORIDA SECARA SIMULTAN PADA SEDIAAN TABLET

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.