Compatible Stability of Levetiracetam Injection with Three Injections
10.6039/j.issn.1001-0408.2017.14.11
- VernacularTitle:左乙拉西坦注射液与3种注射液的配伍稳定性考察
- Author:
Fengling HUANG
;
Yanxia SONG
;
Zhi LI
;
Xiaoli MA
;
Mingbo YANG
;
Bo LI
- Keywords:
Levetiracetam injection;
Sodium chloride injection;
Glucose injection;
Sodium lactate Ringer's injection;
Com-patiblity;
Stability;
HPLC
- From:
China Pharmacy
2017;28(14):1911-1916
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To investigate the compatible stability of Levetiracetam(Lev)injection with 3 injections. METHODS:Each Lev injection 1000 mg mixed with 0.9% Sodium chloride injection 100 mL,5% Glucose injection 100 mL or Sodium lactate Ringer's injection 100 mL respectively. Under the light condition,at 25 ℃,the color and clarification degree of mixtures were ob-served at different time points within 24 h after mixing;pH value and the number of insoluble particles were determined. The contents of related impurities(impurity A,B,C,D,2-hydroxypyridine)and Lev in mixtures were determined by HPLC. RESULTS:Under above condition,all mixtures were colorless clear liquid within 24 h;pH value had no significant change (RSD<1%,n=7);the number of insoluble particles was no more than the range stated in Chinese Pharmacopeia(2015 edition). Impurity B and C were not detected;the contents of other impurities were in line with the requirements of foreign pharmacopeia. No marked change was noted for relative content of Lev(RSD<1%,n=7). CONCLUSIONS:After mixing with 0.9% Sodium chloride injection,5% Glucose injec-tion or Sodium lactate Ringer's injection,Lev injection keep stable at 25℃within 24 h under the light condition.
