Determination of Vonoprazan Pyroglutamate and Vonoprazan Fumarate by HPLC
10.3969/j.issn.1008-049X.2018.03.050
- VernacularTitle:HPLC法测定沃诺拉赞焦谷氨酸盐及富马酸盐的含量
- Author:
Yuan QIAO
1
;
Jianlin HUANG
;
Yuan XU
;
Jun ZHAO
;
Qingwei WANG
Author Information
1. 延安大学附属医院临床药学科 陕西延安716000;第四军医大学唐都医院药剂科
- Keywords:
Vonoprazan pyroglutamate;
Vonoprazan fumarate;
HPLC
- From:
China Pharmacist
2018;21(3):535-538
- CountryChina
- Language:Chinese
-
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.
