GIOVANNI YESSYNIA GUNAWAN, 051311133120 (2017) OPTIMASI DAN VALIDASI METODE KCKT UNTUK PENETAPAN KADAR KLORFENIRAMIN MALEAT DALAM SIRUP OBAT BATUK. Skripsi thesis, UNIVERSITAS AIRLANGGA.

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Abstract

A high performance liquid chromatographic (HPLC) method for determination of chlorpheniramine maleate in cough syrup containing chlorpheniramine maleate, paracetamol, guaifenesin, and ephedrine HCl has been optimized and validated. The optimum condition of the method was achieved on Agilent Hypersil BDS C-18 (250 x 4.6 mm, 5 μm) column with the mobile phase consisting of 0,05 M potassium dihydrogen phosphate buffer pH 3 adjusted with 85% of ortho phosphoric acid and methanol in the ratio 40:60 v/v in isocratic system at the flow rate of 1,0 mL/min. The detection was carried out at 230 nm and the column temperature was set at 25°C. Using this method, retention time of chlorpheniramine maleate was 5.851 minutes. The validation parameters, including specificity, linearity, accuracy, and precision were evaluated. Specificity test showed that no peaks detected at retention time of chlorpheniramine maleate. The method showed good linearity over the concentration between 80.00 and 320.00 μg/mL with correlation coefficient r > 0.999 and Vxo < 5%. The accuracy of the method was found to be 100.005% with precision (RSD) less than 2%. The proposed method was proved to be valid and could be used for determination of chlorpheniramine maleate in cough syrup containing chlorpheniramine maleate, paracetamol, guaifenesin, and ephedrine HCl.

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