Determination of Related Substances in Pantoprazole Sodium for Injection by HPLC
10.6039/j.issn.1001-0408.2017.15.35
- VernacularTitle:HPLC法测定注射用泮托拉唑钠中的有关物质
- Author:
Jing ZHANG
;
Lijie ZHAI
;
Lina GAO
- Keywords:
HPLC;
Pantoprazole sodium for injection;
Related substances;
Determination
- From:
China Pharmacy
2017;28(15):2142-2145
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the determination of related substances in Pantoprazole sodium for injec-tions. METHODS:HPLC method was adopted. The determination was performed on Kromasil Hypersil ODS column with mobile phases consisting of 0.01 mol/L potassium dihydrogen phosphate buffer solution(pH adjusted to 7.0)-acetonitrile(gradient elution) at a flow rate of 1.0 mL/min. The detection wavelength was set at 290 nm,and the column temperature was 40 ℃,and injection volume was 20 μL. RESULTS:The linear ranges of impurity A,impurity B,impurity C+E,and impurity D were 0.4168-1.0420μg/mL(r=0.9998),0.1950-0.4875 μg/mL(r=0.9999),0.3890-0.9725 μg/mL(r=0.9998),0.1986-0.4965 μg/mL(r=0.9998), respectively. The limits of quantitation were 0.834,0.780,1.556,0.794 ng/mL;the limits of detection were 0.417,0.390,0.778, 0.397 ng/mL,respectively. RSD of precision test was lower than 1.0%;in repetitive test,RSD for total peak area of impurity was lower than 1.0% ;the recoveries were 98.81% -102.49%(RSD=1.18% ,n=9),95.31% -98.44%(RSD=0.91% ,n=9), 96.88%-98.44%(RSD=0.52%,n=9)and 97.87%-101.28%(RSD=1.05%,n=9). CONCLUSIONS:The method is convenient, accurate and suitable for the determination of related substance in Pantoprazole sodium for injection.
