Determination of Four Kinds of Residual Organic Solvents in Methylprednisolone Sodium Succinate by GC-Second Order Temperature Programming
- VernacularTitle:气相色谱-二阶程序升温法测定甲泼尼龙琥珀酸钠中4种有机物质残留量
- Author:
Hai HAN
- Publication Type:Journal Article
- Keywords:
Gas chromatogram;
Methanol;
Acetonitrile;
Pyridine;
Dimethylformamide;
Methylprednisolone Sodium Succinate
- From:
China Pharmacy
2001;0(07):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To establish a method of GC-Second Order Temperature Programming for determining the residual quantities of 4 organic solvents-methanol, acetonitrile, pyridine and dimethylformamide-in Methylprednisolone Sodium Succinate. METHODS: The separation was performed on DB-5 capillary column, with flame ion monitor as detector, and with high pure nitrogen, air and hydrogen as carrier gas. The column temperature was subjected to GC-Second Order Temperature Programming, with the temperature of sample injector at 200℃ and that of detector at 220℃. The make-up gas was high pure nitrogen. The split ratio was 10∶1. The sample size was 2?L and the butanone was taken as the internal standard. RESULTS: The four kinds of solvents were linear within their respective concentration range. The average recoveries of methanol, acetonitrile, pyridine and dimethylformamide were 99.4%, 99.2%, 99.3% and 99.0%, respectively, with RSD at 1.8%, 1.8%, 2.0% and 1.7%, respectively. CONCLUSION: The method was proved to be sensitive, accurate and simple.