In vitro Dissolution of Olanzapine Pamoate Long-acting Injections
- VernacularTitle:奥氮平双羟萘酸盐长效注射剂体外溶出度的测定
- Author:
Qiongyan GU
;
Meiyuan WU
- Publication Type:Journal Article
- Keywords:
Olanzapine pamoate long-acting injections;
In vitro dissolution;
HPLC
- From:
China Pharmacist
2014;(12):2053-2056
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop a dissolution method for olanzapine pamoate long-acting injections. Methods:The in vitro dis-solution profile of olanzapine pamoate was detected by an oar method and an HPLC method. The stirring speed respectively was 25, 50 and 75 r·min-1, and 500 ml of sodium lauryl sulfate simulated muscle fluid [0.5% , with pH of (7.0 ±0.05)] at (37 ±0.5)℃was used as the bio-relevant dissolution media. Results: The linearity between the peak areas and the concentrations was observed within the range of 2. 15-107. 40 mg·L-1(r=0. 999 9) for pamoate and 1. 75-87. 40 mg·L-1(r=0. 999 9) for olanzapine, respec-tively, and the average recovery of olanzapine pamoate was 99. 80%(RSD=0. 55%, n=9). The f2 for the dissolution in the dissolu-tion medium of shelf-prepared products and the innovation preparations was 70. 80. Conclusion:The dissolution method can be utilized to control the quality of olanzapine pamoate long-acting injections.
