Abstract

Malaria is a public health problem worldwide, especially in tropical countries. Quinine is a cinchona alkaloid used as an alternative treatment of this infection. However, the drug is only available in tablet dosage form in Thailand. Extemporaneous suspension is always prepared for pediatric use in the hospital. The aim of this study was to develop and validate a high performance liquid chromatographic (HPLC) system, according to ASEAN guideline for validation of the analytical procedure, for determination of quinine sulfate in an extemporaneous suspension. The method used a C18 column with mobile phase of 0.1 M ammonium acetate pH 7.0, acetronitrile and methanol (40:25:35 v/v) at a flow rate of 1.0 mL/min. Injection volume was 50 µL, and UV detection was measured at 330 nm. The result showed that the retention time of quinine was about 7.73 min, and the method was specific to quinine while other excipients in the preparation did not interfere the drug. A linear correlation was obtained over the concentration range of 0.08-600.00 µg/mL (R² = 0.9999). The method was accurate (99.83±0.92%) and precise (<1.09 % RSD). The limit of detection (LOD) and limit of quantific ation (LOQ) were 4.32 and 13.09 µg/mL, respectively. Forced degradation showed that the method would serve as a stability-indicating procedure that applied for analysis of the drug in the stability studies. It concluded that the validated method was accurate and reliable to determine quinine sulfate in the extemporaneous suspension.