Method for determining antioxidant BHT in insulin glargine injection

A technology of insulin glargine and injection, applied in the field of drug packaging and drug compatibility, can solve the problems of not being able to detect BHT well, not being able to obtain ideal results, and being difficult to popularize, so as to achieve accurate and reliable test results and less time-consuming , the effect of reducing operational errors

Active Publication Date: 2016-04-27
广东省医疗器械质量监督检验所
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AI Technical Summary

Problems solved by technology

Traditionally, GC-MS is mostly used for the detection of BHT migration, but this method has high requirements for instruments and is difficult to popularize
[0005] Insulin glargine injection is an insulin analogue, which is mainly used for diabetes that requires insulin treatment. The BHT in the rubber plug also has the possibility of migrating into insulin glargine injection. Traditional techniques cannot detect insulin glargine well. BHT in injections, so improvements are necessary for this
[0006] In the 2015 issue of "Pharmaceutical Today" "High Performance Liquid Chromatography for Antioxidant BHT in Fat Emulsion Injection" article introduced the method of using high performance liquid chromatography to detect BHT in fat emulsion injection. Fat emulsion injection has a good detection effect, but it needs a complicated pretreatment process before detection. When this method is applied to insulin glargine injection, ideal results cannot be obtained

Method used

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  • Method for determining antioxidant BHT in insulin glargine injection
  • Method for determining antioxidant BHT in insulin glargine injection
  • Method for determining antioxidant BHT in insulin glargine injection

Examples

Experimental program
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Effect test

Embodiment 1

[0029] Test object: Antioxidant BHT;

[0030] Detection matrix: insulin glargine injection, which is a solution for injection administration;

[0031] Detection method: high performance liquid chromatography, C18 packed chromatographic column, ultraviolet detector, mobile phase is acetonitrile: water: phosphate buffer, the volume ratio of the three is 65:10:25, the column temperature is 35℃, the flow rate is 1ml / min , The detection wavelength is 280nm;

[0032] The preparation of the phosphate buffer is as follows: take 20.7 g of sodium dihydrogen phosphate dihydrate, add 800 ml of water to dissolve, adjust the pH to 2.5 with phosphoric acid, add 12.8 g of sodium chloride, and add water to 1000 ml.

[0033] 1. Specificity test

[0034] Take 5ml of insulin glargine injection and add 1ml of BHT standard mother liquor, dilute to 10ml with methanol, and enter 20μl of high performance liquid chromatograph according to the above chromatographic conditions. Such as figure 1 As shown, the re...

Embodiment 2

[0053] Except that the column temperature is 40℃, the flow rate is 1.5ml / min, acetonitrile: water: phosphate buffer=75:10:15, the phosphate buffer is prepared with 12.4g sodium dihydrogen phosphate dihydrate and 0g sodium chloride In addition, other conditions are the same as in Example 1.

[0054] After testing, during linearity test, BHT has good linearity within 0.4364~21.82μg / ml, R 2 =0.9997; In the precision test, the RSD is between 0.21~0.76%; in the stability test, the RSD is between 0.59~1.54%; in the insulin glargine injection recovery rate test, the average recovery rate is 98.12~109.31% The RSD is between 0.13 and 0.54%. In summary, this method can accurately detect the antioxidant BHT.

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Abstract

The invention discloses a method for determining antioxidant BHT in an insulin glargine injection and belongs to the field of drug packaging and drug compatibility. The method specifically adopts a HPLC (high performance liquid chromatography) method for detection, a mobile phase comprise acetonitrile, water and a phosphate buffer, a complex preprocessing means is avoided, a chromatographic peak of the antioxidant BHT is separated successfully from chromatographic peaks of insulin glargine and m-cresol according to the method, a trailing phenomenon is avoided, and the content of the antioxidant BHT in a sample is detected accurately.

Description

Technical field [0001] The invention relates to the field of drug packaging and drug compatibility, and in particular to a method for determining the antioxidant BHT in insulin glargine injection. Background technique [0002] Pharmaceutical packaging materials play a vital role in ensuring the stability of drugs and are closely related to people's drug safety. Improper selection of packaging materials for medicines can cause the migration, adsorption and even chemical reactions of the active ingredients of the medicines, making the medicines ineffective, and some may cause serious side effects. [0003] Compared with natural rubber, medicinal butyl rubber stopper has become one of the more widely used materials in medical packaging due to its good air tightness, stability, aging resistance and low precipitation. Since the composition of the rubber stopper is more complicated and contains more types of compounds, as a packaging material that directly contacts the medicine, even if...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06
CPCG01N30/06
Inventor 曲亚南方旻谢新艺颜林
Owner 广东省医疗器械质量监督检验所
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