Optimasi Fase Gerak Kromatografi Cair Kinerja Tinggi untuk Penetapan Kadar Parasetamol, Gliseril Guaiakolat, Klorfeniramin Maleat, dan Fenilefrin HCL dalam Sediaan Tablet Secara Simultan

Abstract

At market, there are various preparations combining two or more active ingredients in the preparation, one of them is cold medicine containing of paracetamol, glyceryl guaiacolate, chlorpheniramine maleate and phenylephrine HCl. These preparations, level will be determined by high performance liquid chromatography. The aim of this research is to determine those four levels of the active substances simultaneously because they have not been found either in FI or at USP. Research was carried out by optimizing the mobile phase which will be used, that were methanol:phosphate buffer pH 4,1; pH 4,3; and pH 4,6. It's also optimizing the ratio of mobile phase, that were 3:7; 4:6; 5:5; 6:4 dan 7:3. High performance liquid chromatography method then tested its validity based on liniearity, accuracy, precision, LOD and LOQ. Then, the methods were applied to determine the levels of paracetamol, glyceryl guaiacolate, chlorpheniramine maleate and phenylephrine HCl in tablet dosage form. The results showed that mobile phase methanol combination phosphate buffer pH 4,3 (60:40), flow rate 1 ml/minute and detected at wavelength of 263 nm can be used to determine the levels of paracetamol, glyceryl guaiacolate, chlorpheniramine maleate and phenylephrine HCl by HPLC. The results of Supraflu® tablet meet the requirements levels specified, phenylephrine HCl, paracetamol, glyceryl guaiacolate, and chlorpheniramine maleate 99,2362% ± 0,4493%; 96,0242% ± 0,2180%; 97,98700/4 ± 0,7435% dan 101.4191% ± 0,7106% respectively. The validation test showed the percentage recovery of phenylephrine HCl 100,7751%, paracetamol 100,2548%, glyceryl guaiacolate 99,8530% and chlorpheniramine maleate 100,7074%. The validation methods fulfilled all of the parameters in validation.