Abstract

VALIDATION OF TLC – DENSITOMETRIC METHOD FOR QUALITY CONTROL OF AMOXICILLIN IN DOSAGE DRUG PRODUCTS

Valentina Petkova, Dobrina Doncheva Tsvetkova *, Danka Petrova Obreshkova,Milen Dimitrov, Stojan Papanov, Peter Atanasov

ABSTRACT

The aim of current study was the validation of TLC densitometric method for routine quality control of Amoxicillin in different dosage forms. The applied conditions were: TLC aluminium plates (Merck) precoated with Silicagel G60F254; mobile phase: ethyl acetate: water: acetic acid = 60 : 20 : 20 v/v. Densitometric analysis was carried out at λ = 254 nm. The obtained regression equation y = 22001110.x – 8392 show the proportional accordance 3D = f (C) in linearity range: 5.10-3 g/ml  1.10-1 g/ml. The calculated correlation coefficient is 0.997. The results of the recovery studies presented in R [%]  RSD (%) suit respective confidence interval: model mixtures: 1) RС400: 100.25 %  0.5 %; 2) RС500: 99.88 %  0.39 %; 3) RС600: 100.2 %  0.33 % and drug products: Amopen caps. 250 mg: 101.96 %  3.94 %; Duomox talb. 375 mg: 101.58 %  2.32 %; Amopen caps. 500 mg: 100.23 %  2.49 %; Ospamox filmtabl. 500 mg: 99.91 %  1.54 %. All results for obtained quantity of Amoxicillin suit respective confidence range: model mixtures: С400: 400.99 mg  1.99 mg; С500: 499.43 mg  1.95 mg; С600: 601.19 mg  1.98 mg and drug products: Amopen caps. 250 mg: 254.89 mg  10.06 mg; Duomox talb. 375 mg: 380.91 mg  8.85 mg; Amopen caps. 500 mg: 501.14 mg  12.49 mg; Ospamox filmtabl. 500 mg: 499.55 mg  7.69 mg; Ospamox filmtabl. 1000 mg: 999.24 mg  7.67 mg.

Keywords: TLC densitometry, Amoxicillin, validation, quality control.