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High performance liquid chromatography analysis method of stannous sodium glucoheptonate related substances for injection

A technology of high performance liquid chromatography and sodium glucoheptonate, applied in the field of drug analysis, can solve the problem of no related substance check items, etc., and achieve the effects of being conducive to safe promotion and application, rapid and accurate detection and monitoring

Active Publication Date: 2021-10-19
HTA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its current quality standard is the standard YBH00542010 issued by the State Food and Drug Administration, and there is no relevant substance inspection item in this standard

Method used

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  • High performance liquid chromatography analysis method of stannous sodium glucoheptonate related substances for injection
  • High performance liquid chromatography analysis method of stannous sodium glucoheptonate related substances for injection
  • High performance liquid chromatography analysis method of stannous sodium glucoheptonate related substances for injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0048] Preparation of solvent: water: acetonitrile = 50:50 (v / v).

[0049] Preparation of blank solution: water: acetonitrile = 50:50 (v / v).

[0050] Preparation of blank auxiliary material solution: Weigh 20 mg of urea, add 10 mL of solvent precisely, shake well, and obtain blank auxiliary material solution.

[0051] Preparation of the test solution: Weigh 160 mg of sodium glucoheptonate, 200 mg of urea and 1.6 mg of stannous chloride, add 10 mL of solvent precisely, and shake well to obtain the test solution.

[0052] Preparation of the contrast solution: Accurately measure 0.5 mL of the test solution, put it in a 50 mL measuring bottle, dilute with a solvent to the volume, shake well, and obtain the contrast solution.

[0053] Preparation of sodium glucoheptonate positioning solution: weigh 16 mg of sodium glucoheptonate, accurately add 1 mL of solvent, and shake well to obtain.

[0054] Preparation of biuret positioning solution: take 1 mg of biuret reference substance, ...

Embodiment 1

[0069] Example 1: System Adaptability

[0070] Prepare solvent and control solution according to the analysis method, and carry out chromatographic test according to the analysis method. After the baseline is balanced, take 1 injection of solvent, take 3 consecutive injections of control solution, record the chromatogram and the theoretical plate number of the first injection of sodium glucoheptonate in the control solution, and calculate the peak of 3 injections of sodium glucoheptonate RSD of the area.

[0071] The requirements of various measurement standards are: the number of theoretical plates of the first injection of sodium glucoheptonate in the control solution shall not be less than 3000, and the RSD of the peak area of ​​sodium glucoheptonate in repeated injections of the control solution for three injections shall not be greater than 4.0%. The chromatogram of the first injection of the control solution is shown in figure 1 .

[0072] Table 2 Results of system ad...

Embodiment 2

[0075] Example 2: Specificity

[0076] Take the blank solution, blank excipient solution, test solution, sodium glucoheptonate positioning solution, and biuret positioning solution, and test according to the chromatographic conditions under "Analytical Method", inject 1 needle each, and record the chromatogram. For the chromatogram of the blank solution, see figure 2 ; The chromatogram of the test solution is shown in image 3 ; The chromatogram of sodium glucoheptonate positioning solution is shown in Figure 4 ; Biuret positioning solution chromatogram see Figure 5 .

[0077] The requirements of various measurement standards are: at the retention time of the test solution sodium glucoheptonate, the interference of the blank solution and the blank auxiliary material solution is ≤0.1%. In the chromatogram of the test solution, the separation between the sodium glucoheptonate peak and the adjacent impurity peaks is not less than 1.5.

[0078] At the corresponding retenti...

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Abstract

The invention provides a high performance liquid chromatography analysis method of stannous sodium glucoheptonate related substances for injection, and the high performance liquid chromatography conditions are as follows: a hydrophilic interaction chromatographic column is adopted, the mobile phase is composed of 6 to 9mM trifluoroacetic acid and acetonitrile according to the volume ratio of (30 to 70): (30 to 70), and the detection wavelength is 190 to 220nm. The system adaptability, specificity, precision, accuracy, linearity and range, limit of detection, limit of quantitation and durability verification of the method all meet acceptable standards, the quality of the stannous sodium glucoheptonate for injection can be rapidly and accurately detected and monitored, safe popularization and application of the stannous sodium glucoheptonate for injection are facilitated, and the problem that no related substance detection method for stannous sodium glucoheptonate for injection exists is solved.

Description

technical field [0001] The embodiment of the present invention relates to the technical field of drug analysis, in particular to a high performance liquid chromatography analysis method for related substances of stannous glucoheptonate sodium for injection. Background technique [0002] Sodium stannous glucoheptonate for injection belongs to radiopharmaceuticals and was approved for marketing in 1998 (National Drug Approval H10980080), which is used to prepare technetium[ 99m Tc] dicysteine ​​injection. Technetium [ 99m Tc] Dicysteine ​​injection can penetrate the blood-brain barrier, has a fixed distribution in the brain, has high brain uptake, long residence time, and is stable in vitro, suitable for clinical use, and is an ideal brain perfusion SPECT imaging agent. It is clinically used for cerebral blood perfusion SPECT imaging of various cerebrovascular diseases (infarction, hemorrhage, transient ischemic attack, etc.), epilepsy, dementia, brain tumor and other diseas...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 孙钰林张丛黄旭虎秦祥宇李泽全孙明月陈孟毅
Owner HTA CO LTD
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