The present application relates to the technical field of pharmaceutical analysis, and specifically discloses a method for detecting the purity of
doxycycline for injection. The present application mainly solves the problems caused by
ion pair
reagent and high-salt buffer in the existing chromatographic method, such as serious
pollution of the
system pipeline and the
chromatographic column, difficulty in connecting with
mass spectrometry for
impurity structure identification, and insufficient separation degree of key polar impurities such as 4-epi
doxycycline. The present application purifies the sample by physical
dilution and
filtration, and prepares uniform
aerosol by
ultrasonic atomization. The
ion mobility spectrometry technology is adopted to realize the efficient separation of gas-phase ions under a weak
electric field according to the difference in
ion collision cross section (CCS) value, and the
epimer which is difficult to distinguish by traditional methods can be excellently separated. The multi-
modal sensor is used to synchronously collect
ultraviolet, fluorescent and terahertz multi-dimensional optical signals. Finally, based on the intrinsic physical parameter
database, the intelligent analysis is carried out by using the
machine learning
algorithm, and the qualitative and quantitative results are automatically output.