Optimasi Fase Gerak Kromatografi Cair Kinerja Tinggi Pada Penetapan Kadar Parasetamol, Gliseril Guaiakolat, Klorfeniramin Maleat, dan Fenilefrin Hcl Dalam Sediaan Tablet Secara Simultan:

Mobile Phase Optimization of High Performance Liquid Chromatography for Simultaneous Determination of Paracetamol, GlycerylGuaiacolate, Chlorpheniramine Maleate, and Phenylephrine HCl in aTablet Dosage Form

Abstract

Di pasaran, terdapat berbagai sediaan obat yang mengkombinasikan dua atau lebih zat aktif dalam satu sediaan, salah satunya adalah obat flu yang mengandung parasetamol, klorfeniramin maleat, gliseril guaiakolat dan fenilefrin hidroklorida. Penelitian ini bertujuan untuk menetapkan kadar keempat campuran zat aktif tersebut secara simultan karena analisis keempat campuran zat aktif tersebut belum ditemukan baik di Farmakope Indonesia maupun di United States Pharmacopoeia. Penelitian dilakukan dengan mengoptimasi berbagai jenis campuran fase gerak yaitu metanol dengan buffer fosfat pH 4,1; metanol dengan buffer fosfat pH 4,3 dan metanol dengan buffer fosfat pH 4,6. Selain itu juga dilakukan optimasi berbagai perbandingan fase gerak yaitu 30:70; 40:60; 50:50; 60:40 dan 70:30. Hasil penelitian menunjukkan bahwa kombinasi fase gerak metanol:buffer fosfat pH 4,3 dengan perbandingan fase gerak 60:40; laju alir 1 ml/menit dan dideteksi pada panjang gelombang 263 nm dapat digunakan untuk menetapkan kadar parasetamol, klorfeniramin maleat, gliseril guaiakolat dan fenilefrin hidroklorida secara KCKT. Hasil kadar pada sediaan tablet Supraflu® memenuhi persyaratan yaitu diperoleh kadar fenilefrin HCl, parasetamol, gliseril guaiakolat dan klorfeniramin maleat berturutturut adalah 99,2362% ± 0,4493%; 96,0242% ± 0,2180%; 97,9870% ± 0,7435% dan 101.4191% ± 0,7106%.

There are numerous drug preparations that consist two or more active substances in a fixed combination dosage form . One of them is flu remedies containing paracetamol, chlorpheniramine maleate, glycerylguaiacolate, and phenylephrine hydrochloride. This study aimed to determine the levels of the four mixtures of active substances simultaneously because the analysis of the four mixtures of active substances had not been found either in Indonesian Pharmacopoeia or in the United States Pharmacopoeia. The study was conducted by optimizing various types of mobile phase mixtures, i.e. methanol-phosphate buffer at pH 4.1, methanol- phosphate buffer at pH 4.3, and methanol-phosphate buffer at pH 4.6. Besides that, optimization of various mobilephase ratios were also conducted, i.e. 30:70; 40:60; 50:50; 60:40 and 70:30. The results showed that the mobilephase combination of methanol-phosphate buffer at pH 4.3 with a mobilephase ratio of 60:40; flow rate of 1 ml/minute and detection wavelength at 263 nm could be used to determine the levels of paracetamol, chlorpheniramine maleate, glycerylguaiacolate, and phenylephrine hydrochloride using HPLC. The results of the levels in Supraflu® tablet preparations met the requirements, where levels of phenylephrine HCl, paracetamol, glycerylguaiacolate and chlorpheniraminemaleate   were 99.2362% ± 0.4493%; 96,0242% ± 0,2180%; 97.9870% ± 0.7435% and 101.4191% ± 0.7106%, respectively.