Determination of Related Substances in Asenapine Maleate by HPLC
- VernacularTitle:高效液相色谱法测定马来酸阿塞那平的有关物质
- Author:
Yan QI
;
Yuanfeng TONG
;
Chunyan WANG
;
Dongmei WANG
;
Song WU
- Publication Type:Journal Article
- Keywords:
Asenapinemaleate;
HPLC;
Relatedsubstances
- From:
China Pharmacist
2014;(10):1655-1659
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop a quantitative HPLC method for the analysis of eight impurities in active pharmaceutical ingredi-ent (API) asenapine maleate. Methods:The substances were analyzed using an Inertsil ODS-3 C18 column (250 mm × 4. 6 mm, 5μm), and gradiently eluted by the mobile phase A of 0. 1% aqueous trifluoroacetic acid and mobile phase B of acetonitrile in a flow rate of 1. 0 ml·min-1 with the detection wavelength of 220 nm and the column temperature of 35℃. Results:Asenapine was separa-ted completely from the impurities. The calibration curve of asenapine was linear within the range of 0. 45-1 458 μg · ml-1 ( r =1. 000 0), and that the impurities was linear within the range of 0. 4-30. 0μg·ml-1(r>0. 999). The mean recovery of the impurities was 93. 1%-106. 7%(n=9). Conclusion:The method is simple,sensitive and reproducible with good specificity and reliability,which can be used in the quality control of asenapine maleate.
