A kind of lc-ms analysis method of acid chloride derivatives
A LC-MS and derivative technology, applied in the field of medicine and chemical industry, can solve the problems of undetermined fragment ions, poor method reproducibility, and slow reaction of derivative reactions, etc.
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[0067] In order for those skilled in the art to better understand the technical solutions of the present invention, some non-limiting examples are further disclosed below to further illustrate the present invention in detail.
[0068] The reagents used in the present invention can be purchased from the market or can be prepared by the method described in the present invention.
[0069] The analytical reagents and solutions used in the present invention meet the requirements of the appendix of the 2010 edition of the Chinese Pharmacopoeia, unless otherwise specified.
[0070] In the following examples, the test sample is the sample to be tested.
Embodiment 1
[0071] Embodiment 1 Verification of ethyl chloroformate residual method in ritonavir
[0072] Instruments, reagents, reference substances and test substances:
[0073] Instruments: 1 / 100,000 analytical balance, liquid chromatography-mass spectrometer;
[0074] Reagent: dichloromethane (HPLC grade);
[0075] Control substance: ethyl chloroformate (AR grade)
[0076] Derivative: N,N-diisopropylethylenediamine
[0077] Test article: ritonavir
[0078] Solution preparation:
[0079] Blank solution / diluent: take about 20mg of N,N-diisopropylethylenediamine into a 25ml volumetric flask and shake well; take an appropriate amount into a liquid phase vial;
[0080] Reference substance mother liquor 1: Take about 39.06 mg of ethyl chloroformate (limit of 1.25), accurately weigh it, put it into a 50 mL volumetric flask, dissolve it with dichloromethane and dilute to volume, shake well;
[0081] Reference substance mother solution 2: Precisely pipette 1.0 mL of reference substance m...
Embodiment 2
[0155] Embodiment 2 Determination of ethyl chloroformate residual content in azilsartan medoxomil
[0156] Instruments, reagents, reference substances and test substances
[0157] Instruments: 1 / 100,000 analytical balance, liquid chromatography-mass spectrometer;
[0158] Reagent: dichloromethane (HPLC);
[0159] Control: Ethyl Chloroformate (AR)
[0160] Derivative: N,N-diisopropylethylenediamine
[0161] Test article: Azilsartan
[0162] Solution preparation
[0163] (1) Blank solution / diluent: take about 20 mg of N,N-diisopropylethylenediamine, put it into a 25ml volumetric flask, add dichloromethane to the volume and shake well; take an appropriate amount and put it into a liquid phase vial;
[0164] (2) Reference substance mother liquor 1: Take about 37.5 mg of ethyl chloroformate, accurately weigh it, put it into a 10 mL volumetric flask, dissolve it with dichloromethane, and dilute to volume, shake well;
[0165] (3) Reference substance mother solution 2: Precisel...
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