Determination of Related Substances in Nitroglycerin Injection by HPLC Main Component Reference Substances External Standard Method
Objective:To establish a HPLC method for the determination of related substances in nitroglycerin injection.Method:The separation was performed on a GL Sciences Inertsil ODS-3V C18 column(4.6 mm×250 mm,5 μm)with 0.1%phosphoric acid as mobile phase A and methanol as mobile phase B in a gradient elution mode at a flow rate of 1.5 mL·min-1;the column temperature was 40℃;the detection wavelength was 210 nm;the injection volume was 20 μL.The impurity content was calculated by external standard method of the principal component reference substance with the correction factor.Results:Under the established chromatographic parameters,there was no interference with the blank excipient,and the impurities were well separated with good linearity.The limits of detection(LOD)of impurities B,C,D and E were 0.07 μg·mL-1,0.07 μg·mL-1,0.06 μg·mL-1,0.06 μg·mL-1,and the limits of quantification(LOQ)were 0.15 μg·mL-1,0.15 μg·mL-1,0.15 μg·mL-1,0.15 μg·mL-1,with the average recoveries were 103.6%,99.9%,106.7%,109.0%,and the RSD were 0.6%,0.6%,1.5%,1.2%,respectively.Conclusion:The method is easy to operate,with high sensitivity and good specificity,and can be used for the quality control of related substances in nitroglycerin injection.
nitroglycerin injectionrelated substancesmain component reference substance external standard method
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