RESUMO
This study was aimed to establish determination method of content and related substances of piperaquine in A rtemisinin and Piperaquine Tablets, and to set the limit of related substance. HPLC was adopted on a SHISEIDO CAPCELL PAK C18 (4.6 mm í 250 mm, 5 μm) using an isocratic mobile phase consisted of acetonitrile: 0.1%trichloroaceticacid:triethylamine (18:82:0.2, V:V:V, pH 2.5) with a flow rate of 1.0 mL·min-1. The column tempera-ture was kept at 30oC and the detection wavelength was set at 216 and 237 nm, separately for the determination of related substance and content. The results showed that piperaquine and its related impurity can be separated effec-tively. The concentration-response relationship was linear over the range of 0.01-0.2 mg·mL-1 (R2=0.999 9). The av-erage recovery rate was 98.14% (RSD=0.77%, n=9). The minimum detection limit was 0.06 μg·mL-1. The solution was stable for 12 h. It was concluded that the method was specific, accurate, sensitive and suitable for the determi-nation of content and related substances of piperaquine in A rtemisinin and Piperaquine Tablets.
RESUMO
Infrared (IR) spectroscopy was employed to identify the Artemisinin and Piperaquine Tablets. Artemisinin and piperaquine was extracted separately by different solvents, and IR spectra were collected. IR absorption spectrum of the extract was concordant with the reference spectrum recorded in the Atlas of Infrared Spectra of Drugs, except for a group of small absorptions at 1 574 cm-1 for the artemisinin extract. It was concluded that IR method is stable and accurate, which can be used to identify the Artemisinin and Piperaquine Tablets.