Storage life of nitroglycerin injection at room temperature determined by High-performance liquid chromatography
Objective To determine the content of nitroglycerin injection by High-performance liquid chromatography and to pre-dict the shelf life of nitroglycerin injection at room temperature.Methods(1)HPLC method was established for the content determi-nation of nitroglycerin injection.Kromasil C18,5 μm column was used,methanol:water(59∶41)was used as mobile phase,the flow rate was 1.0 ml·min-1,detection wavelength was 215nm,column temperature was 30℃,the quantitative determination of nitroglycerin injection was carried out.(2)The initial stability of the nitroglycerin injection was studied by accelerated and long-term retention tests,and its shelf life at room temperature was predicted by classical isothermal tests.Results The HPLC method for the determination of nitroglycerin injection was investigated.The results showed that the detection concentration of nitroglycerin injection was in the range of 10 µg·ml-1-600 µg·ml-1 and the peak area was linear(R=0.9999).RSDs of intra-day precision,inter-day precision,stability test and repeatability test were all less than 2％.The average value of content determination was 99.99 µg·ml-1(standard value 100 µg·ml-1),and the recovery rate was 1.67％.At 25℃,the rate constant of nitroglycerin injection was K25=7.1395 × 10-4,and the storage time of nitro-glycerin injection was 147 days,at 30℃,K30=9.4175 × 10-4,the storage time of nitroglycerin injection was 111 days.The reliability of the experiment can be verified by long-term observation.Conclusion The detection method is simple,rapid,high precision and good repeatability.The storage period of nitroglycerin injection at room temperature is about 5 months,which can provide reference for clini-cal management of rescue vehicle drugs.
High-performance liquid chromatographyNitroglycerin injectionClassical thermostatic methodStorage time
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