VALIDASI METODE KLT-DENSITOMETRI UNTUK PENETAPAN KADAR KLORFENIRAMIN MALEAT DALAM SEDIAAN TABLET YANG MENGANDUNG TARTRAZIN

The determination of chlorpheniramine maleate (CTM) in tablet is very important to ensure the safety of a drug. Chlorpheniramine maleate tablets usually contain yellow dyes, most of them are tartrazine. Tartrazine should not interfere the determination of chlorpheniramine maleat in tablet. The purpose of this study was to obtain a valid TLC-Densitometry method for the determination of chlorpheniramine maleate in tablet containing tatrazine. The mobile phase of ethyl acetate: methanol: ammonium hydroxide (100: 15: 15) was used for separation CTM from tartrazine on TLC plate. The validation of the method includes selectivity, linearity, accuracy, and precision. The linearity obtained was r = 0.9970, Vxo = 3.28%. This study, used two methods for determination accuracy. The first method, the spiked placebo recovery and the second method was standard addition. Those two methods obtained average chlorpheniramine maleate recovery of 76,06% ± 2,05 with coefficient variation of precision was 2,69% and 72,91% ± 14,20 with coefficient variation of precision was 19,48%, respectively. From those results, it can be concluded that accuracy and precision did not meet the validation criteria