Structural Analysis of Impurities in Aciclovir Tablets by HPLC-MS/MS
OBJECTIVE To analysis the structures of the impurities in aciclovir tablets and the compulsory degradation samples by high performance liquid chromatography coupled with hybrid quadrupole orbitrap mass spectrometry technology(HPLC-Q-Exactive Orbitrap-MS).METHODS The HPLC separation was carried out on a Waters Xbridge BEH Shield RP18(4.6 mm×250 mm,5 μm)by the gradient elution with a mobile phase consisting of 10 mmol·L-1 ammonium formate solution(0.15％formic acid)(A)and 10 mmol·L-1 ammonium formate solution(0.15％formic acid)-acetonitrile(50:50)(B),and the detection wavelength was 254 nm.The Q-Exactive Orbitrap-MS was used to determine the precise first-order molecular weight and second-order fragment ions of these impurities,and the structures were identified.RESULTS Aciclovir and its impurities were well separated,and 8 major impurities with content＞0.1％were detected and identified in aciclovir tablets and the compulsory degradation samples.Among them,4 were the impurities listed in the European Pharmacopeia 10.0,and the others were unknown impurities identified for the first time.CONCLUSION The LC-MS/MS method can effectively identify the impurities in aciclovir tablets,which is significant for the production process optimization and quality control.
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