Method for determining content of sodium hydrogen sulfite in azasetron hydrochloride sodium chloride injection

A technology of azasetron hydrochloride, sodium chloride and sodium bisulfite, which is applied to measurement devices, instruments, scientific instruments, etc., can solve the problems of large sample volume, large blank interference, and complicated method for sodium bisulfite content. , to achieve the effect of high selectivity

CN112666289APending Publication Date: 2021-04-16CISEN PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
Publication Date
2021-04-16

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Abstract

The invention discloses a method for determining the content of sodium hydrogen sulfite in an azasetron hydrochloride sodium chloride injection. According to the method, the content of sodium hydrogen sulfite in the azasetron hydrochloride sodium chloride injection is determined by adopting an ion chromatography method. Chromatographic conditions are as follows: chromatographic columns: an AG-11 anion protection column and an AS-11 anion analysis column; the leacheate is a 20 mmol / L potassium hydroxide solution; the flow rate is 1.0 mL / min; a suppression-type conductivity detector has a suppression voltage of 50 mV; and the sample size is 25mu L. Compared with an existing detection method, the method is simpler, more sensitive, more economical, more stable and higher in selectivity.
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Description

technical field

[0001] The invention belongs to the technical field of drug analysis and detection, in particular to a method for determining the content of sodium bisulfite in azasetron hydrochloride sodium chloride injection. Background technique

[0002] Azasetron Hydrochloride Sodium Chloride Injection is an antiemetic drug used for nausea and vomiting caused by radiotherapy, cytotoxic drug chemotherapy, and nausea and vomiting in patients after surgery. Some manufacturers add sodium bisulfite as an antioxidant. Unlike oral administration, allergic reactions to sulfites administered intravenously are rapid onset and severe. Because oral sulfite is absorbed in the intestine and enters the liver through the portal vein, and is oxidized by intrahepatic sulfite oxidase into non-toxic sulfate and excreted in the urine. Intravenously administered sulfite bypasses the liver detoxification link and enters the blood circulation. More toxic. The usual dose of sulfite in injectio...

Examples

Embodiment 1

[0015] 1. Prepare the solutions used in the assay:

[0016] (1) Preparation of 0.4% formaldehyde solution: take 4.0mL formaldehyde solution, put it in a 100mL volumetric flask, add water to dilute to the mark, shake well, and you get it;

[0017] (2) Preparation of the test solution: accurately measure 2 mL of azasetron hydrochloride sodium chloride injection, put it in a 20 mL volumetric flask, dilute to the mark with 0.4% formaldehyde solution, shake well, and obtain;

[0018] (3) Preparation of sodium bisulfite reference substance solution: Accurately weigh 100 mg of sodium bisulfite reference substance, place it in a 100 mL volumetric flask, add water to dissolve, and dilute to the mark with water, accurately pipette 2 mL, place it in a 100 mL volumetric flask, and use 0.4 Dilute the % formaldehyde solution to the mark, shake well, and get it;

[0019] (4) Preparation of sodium bisulfate reference substance solution: Accurately weigh 100 mg of sodium bisulfate reference s...