Determination of Related Substances in Foscarnet Sodium by HPLC
10.3870/j.issn.1004-0781.2023.12.015
- VernacularTitle:高效液相色谱法测定膦甲酸钠有关物质
- Author:
Ming CHEN
1
;
Shanshan WANG
;
Ge QIAO
;
Miao LI
Author Information
1. 武汉药品医疗器械检验所,国家药品监督管理局药物制剂质量研究与控制重点实验室,武汉 430073
- Keywords:
Foscarnet sodium;
High performance liquid chromatography(HPLC);
Related substances
- From:
Herald of Medicine
2023;42(12):1830-1834
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a method for the determination of related substances in foscarnet sodium by HPLC.Methods The chromatography separation was performed on a CAPCELL PAK C18 chromatography column(250 mm×4.6 mm,5 μm)with mobile phase of a mixture of solution[Solution A:dissolve 3.2 g of sodium sulfate decahydrate in water,add 3 mL of glacial acetic acid and 6 mL of 0.1 mol·L-1 sodium pyrophosphate,dilute with water to 1 000 mL.Solution B:dissolve 3.2 g of sodium sulfate decahydrate in water,add 6.8 g of sodium acetate and 6 mL of 0.1 mol·L-1 sodium pyrophosphate,dilute with water to 1000mL.Solution A and Solution B(70∶30)(the pH of this mixture is about 4.4).To 1 000 mL of this solution add 0.25 g of tetrahexylammonium hydrogen sulfate and 100 mL of methanol]at a flow rate of 1.0 mL·min-1.The column temperature was 35℃.The detection wavelength was 230 nm and the injection volume was 50 μL.Results Under the chromatography conditions,the peaks of foscarnet sodium,impurityⅠ,impurity Ⅱ and other individual impurities were separated effectively.The foscarnet sodium and impurity Ⅱ showed good liner relationships(r=0.999 9)in the range of 5-248 μg·mL-1 and 1.6-9.1 μg·mL-1,respectively.The limits of detection(LODs)of foscarnet sodium and impurity Ⅱ were 23 ng and 62 ng respectively.The average recovery of impurity Ⅰ was 100.8%,RSD= 2.0%(n= 6).The average recovery of impurity Ⅱ was 98.6%,RSD=2.7%(n=12).Conclusion The method is simple,sensitive and accurate.It is suitable for the determination of related substances in foscarnet sodium.
