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Method for measuring concentration of aprepitant in plasma by liquid chromatography-mass spectrometry

A prepitant and liquid mass spectrometry technology, applied in the field of medicine, can solve the problems of not being suitable for large-scale detection of samples, long detection time, and complexity, and achieve the speed of domestic substitution, short detection time, and stable baseline Effect

Pending Publication Date: 2022-07-29
宁波熙宁检测技术有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] At present, there are some reports on the detection of aprepitant based on LC-MS / MS, but the detection time is long, the pretreatment is complicated compared with this patent, and it is not suitable for the needs of large batches of detection samples. Therefore, it is necessary to establish a method with fast and accurate , reliable, and highly sensitive, highly selective method for detecting the concentration of aprepitant in plasma

Method used

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  • Method for measuring concentration of aprepitant in plasma by liquid chromatography-mass spectrometry
  • Method for measuring concentration of aprepitant in plasma by liquid chromatography-mass spectrometry
  • Method for measuring concentration of aprepitant in plasma by liquid chromatography-mass spectrometry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 Experimental materials and analytical equipment

[0058] Aprepitant (analyte): U.S. Pharmacopeial Convention

[0059] Aprepitant-d4 (internal standard): Toronto Research Chemicals

[0060] The reagents used are shown in Table 1 below:

[0061] Table 1 Reagent details

[0062] Reagent name level manufacturer Acetonitrile (ACN) HPLC J.T. Baker Ammonium acetate (CH3COONH4) HPLC J.T. Baker Methanol (MeOH) HPLC J.T. Baker Ascorbic acid (VC) ACS SIGMA-ALDRICH Hydrochloric acid (HCl) AR Greagent

[0063] Note: Reagents of the same grade or higher can also be used

[0064] The analytical equipment used is shown in Table 2 below:

[0065] Table 2 Details of equipment used

[0066] components type manufacturer Binary pump AD Pump SHIMADZU Degasser (Degasser) Degasser SHIMADZU Column oven AD Column oven SHIMADZU Autosampler AC Autosampler SHIMADZU Sa...

Embodiment 2

[0068] Embodiment 2 Liquid phase conditions

[0069] 1. Liquid chromatography conditions:

[0070] Chromatographic column: Agilent ZORBAX XDB-C18, 5μm, column size is 2.1×50mm; Column temperature: 40℃; Mobile phase A: H 2 O / FA=100 / 0.2(V / V); Mobile phase B: ACN / FA=100 / 0.2(V / V); Wash solution: MeOH / H 2 O=50 / 50 (V / V); the temperature of the autosampler is 15°C; the gradient elution, the flow rate is 0.4000mL / min, the injection volume is 10μL, and the analysis time is 3.00min;

[0071] Table 3 Gradient elution procedure

[0072] Total time (min) Flow rate (ml / min) Mobile phase A (%) Mobile phase B (%) 0.00 0.4000 45.0 55.0 0.60 0.4000 45.0 55.0 0.61 0.4000 20.0 80.0 1.20 0.4000 20.0 80.0 1.21 0.4000 45.0 55.0 3.00 0.4000 45.0 55.0

[0073] 2. Mass spectrometry conditions

[0074] Aprepitant conditions are:

[0075] The ion source adopts electrospray ion source, the spray voltage is 5500V, the atomization temperatur...

Embodiment 3

[0079] Example 3 Test process

[0080] 1. Preparation of aprepitant standard solution

[0081] Preparation of aprepitant standard solution: Accurately weigh 5.032 mg of aprepitant (analyte), add MeOH to dissolve to 500000ng / mL, and use MeOH / H in turn 2 O=50 / 50 (V / V) solution is diluted to prepare aprepitant standard solution, and the specific dilution concentration is shown in Table 4 below:

[0082] Table 4 Aprepitant standard solution preparation concentration

[0083]

[0084]

[0085] a: Prepared directly from aprepitant

[0086] b: Dilute solution of analyte: MeOH / H 2 O=50 / 50(V / V)

[0087] Aprepitant standard solution is stored in a brown glass container and refrigerator (-20°C) when not in use, and the volume can be increased or decreased proportionally as needed.

[0088] 2. Preparation of aprepitant-d4 internal standard standard solution

[0089] Preparation of aprepitant-d4 internal standard standard solution: Accurately weigh 1.107 mg of aprepitant-d4 (in...

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Abstract

The invention discloses a method for determining the concentration of aprepitant in plasma by liquid chromatography-mass spectrometry, which comprises the following steps: detecting a pretreated plasma sample by high performance liquid chromatography-tandem mass spectrometry, quantifying and detecting the chromatographic peaks of aprepitant and internal standard aprepitant d4 in the sample by using an internal standard method, and further obtaining the concentration of aprepitant in the plasma sample, wherein the test conditions of the high performance liquid chromatography are as follows: a mobile phase A: H2O / FA = 100 / 0.2 (V / V); a mobile phase B: ACN / FA = 100 / 0.2 (V / V); washing liquid: MeOH / H2O = 50 / 50 (V / V); a gradient elution mode is adopted. The method can be used for accurately and rapidly determining the concentration of aprepitant in human plasma, and can be used for evaluating the consistency of imitated drugs, accelerating the speed of domestic substitution of imported drugs, reducing the treatment cost of patients and improving the drug quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a method for determining a drug, in particular to a method for determining the concentration of aprepitant in plasma by liquid chromatography-mass spectrometry. Background technique [0002] Aprepitant, also known as acetamidazole, is an off-white to pale yellow crystal-like solid chemical, aprepitant is a substrate, mild to moderate (dose-dependent) inhibitor and inducer of CYP3A4, Also a CYP2C9 inducer. Coadministration of aprepitant with drugs that inhibit CYP3A4 activity can lead to increased plasma concentrations of aprepitant. Clinically, aprepitant is mainly used to prevent acute and delayed nausea and vomiting during the initial and repeated treatment of highly emetogenic antitumor chemotherapy. Molecular formula: C 23 H 21 F 7 N 4 O 3 , molecular weight: 534.43, its chemical structure is: [0003] [0004] Chemotherapy-induced nausea and vomiting (CINV) is a ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8822G01N2030/884
Inventor 黄启宽祝永琴胡海俊游亚珍
Owner 宁波熙宁检测技术有限公司
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