Determination of Vonoprazan Pyroglutamate and Vonoprazan Fumarate by HPLC / 中国药师

ABSTRACT

Objective:To develop an HPLC method for the determination of vonoprazan pyroglutamate and vonoprazan fumarate. Methods:The column of Intertsil ODS-3 (150 mm×4.6 mm,5 μm) was used. The mobile phase was composed of methanol and a mixture of 0.15% phosphoric acid(ajust pH of 3 with 0.15% triethylamine solution). Gradient elution was adopted and the flow rate was set at 1.0 ml·min-1. The detection wavelength was 230 nm and the column temperature was 30℃. The sample size was 10 μl. Results: The standard curve of vonoprazan pyroglutamate showed a good linearity over the range of 2.060-131.800 μg·ml-1with a correlation coefficient of 0.999 7. The average spiked recovery of vonoprazan pyroglutamate was 99.40% (RSD=0.63%, n=9). The content of three batches of TAK-438 P was 98.7%,99.0% and 98.4%(n=3),respectively. The standard curve of vonoprazan fumarate showed a good linearity over the range of 1.844-118.000 μg·ml-1with a correlation coefficient of 0.999 9. The average spiked recovery of TAK-438 F was 100.67%(RSD =0.52%, n =9). The content of three batches of vonoprazan fumarate was 98.5%,98.2% and 98.9%(n=3),respectively. Conclusion:A reliable and sensitive HPLC method for the quantification of vono-prazan pyroglutamate is established and validated,which provides the basis for the content determination.