Method for determining related substances of ampicillin sodium and sulbactam sodium for injection

A technology for ampicillin sodium and sulbactam sodium and related substances is applied in the field of determination of related substances of ampicillin sodium and sulbactam sodium for injection, which can solve the problems of measurement interference, low purity, and many impurities, so as to avoid interference and improve the The effect of specificity and sensitivity

Active Publication Date: 2021-06-18
CHINA MEHECO SANYANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The current Ampicillin Sodium Sulbactam Sodium for Injection has the problems of low purity and many impurities. However, in the existing conditions of Ampicillin Sodium Sulbactam Sodium for Injection in the Chinese Pharmacopoeia 2020, the solvent peak overlaps with the Sulbactam Impurity A peak , which interferes with the determination of

Method used

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  • Method for determining related substances of ampicillin sodium and sulbactam sodium for injection
  • Method for determining related substances of ampicillin sodium and sulbactam sodium for injection
  • Method for determining related substances of ampicillin sodium and sulbactam sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The batch number of sodium Sulbartan soda soda soda is used in injection is: T200501.

[0035] Detection method: High performance liquid chromatography, using the standard of the present invention, using octadecyl silicone bile silica gel as a filler (4.6 mM × 250 mM, 5 μm).

[0036] Mobile phase A: 0.02 mol / L of sodium phosphate (pH is adjusted to 3.50 ± 0.05) with a 1 mol / L phosphoric acid solution to 3.50 ± 0.05); mobile phase B: acetonitrile.

[0037] Detection wavelength: 230 nm; column temperature: 40 ° C; flow rate: 1.0mL / min calculation method: 1% self-control method in size: 10 μL ...; linear elution gradient as shown in Table:

[0038] Mobile phase gradient

[0039] T (min) A(％) B(％) 0 98 2 5 93 7 10 93 7 60 60 40 70 60 40 71 98 2 80 98 2

Embodiment 2

[0041] Example 2 is consistent with the detection method of Example 1, and the difference is that the batch number of sodium Sulbawa sodium Sulbawa in injection is: x2873201.

[0042] Detection method: High performance liquid chromatography, using the standard of the present invention, using octadecyl silicone bile silica gel as a filler (4.6 mM × 250 mM, 5 μm).

[0043] Mobile phase A: 0.02 mol / L of sodium phosphate (pH is adjusted to 3.50 ± 0.05) with a 1 mol / L phosphoric acid solution to 3.50 ± 0.05); mobile phase B: acetonitrile.

[0044] Detection wavelength: 230 nm; column temperature: 40 ° C; flow rate: 1.0mL / min calculation method: 1% self-control method in size: 10 μL ...; linear elution gradient as shown in Table:

[0045] Mobile phase gradient

[0046] T (min) A(％) B(％) 0 98 2 5 93 7 10 93 7 60 60 40 70 60 40 71 98 2 80 98 2

Embodiment 3

[0048] Example 3 was consistent with the detection method of Example 1, and the difference is that the batch number of ampicillin sodium Sulbawa soda is used as: 33001713.

[0049] Detection method: High performance liquid chromatography, using the standard of the present invention, using octadecyl silicone bile silica gel as a filler (4.6 mM × 250 mM, 5 μm).

[0050] Mobile phase A: 0.02 mol / L of sodium phosphate (pH is adjusted to 3.50 ± 0.05) with a 1 mol / L phosphoric acid solution to 3.50 ± 0.05); mobile phase B: acetonitrile.

[0051] Detection wavelength: 230 nm; column temperature: 40 ° C; flow rate: 1.0mL / min calculation method: 1% self-control method in size: 10 μL ...; linear elution gradient as shown in Table:

[0052] Mobile phase gradient

[0053] T (min) A(％) B(％) 0 98 2 5 93 7 10 93 7 60 60 40 70 60 40 71 98 2 80 98 2

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Abstract

The invention discloses a method for determining related substances of ampicillin sodium and sulbactam sodium for injection, a high performance liquid chromatography is adopted to detect an ampicillin sodium and sulbactam sodium sample solution for injection, and mobile phases of the high performance liquid chromatography comprise a mobile phase A which is a sodium dihydrogen phosphate solution and a mobile phase B which is acetonitrile, on the basis of the standard of ampicillin sodium and sulbactam sodium for injection in Chinese Pharmacopoeia 2020, the pH value and linear gradient of the mobile phase A are modified, so that main degradation impurity peaks as well as main peaks and adjacent impurity peaks can be effectively separated, meanwhile, a solvent peak and a sulbactam impurity A peak can be effectively separated, and therefore, the interference of a solvent peak on the determination of the sulbactam impurity A is avoided, and the method disclosed by the invention has better specificity and sensitivity and can better control the quality of a product.

Description

Technical field [0001] The present invention relates to the field of substance measurement methods. More specifically, the present invention relates to a method for determination of material for injection of sodium Sulbawa. Background technique [0002] The injection of ampicillin sodium Shuba is a compound formulation, which is a sterile powder that is mixed with ampicillin sodium and Sulbarta sodium. [0003] Ampicillin sodium, chemical name: (2S, 5R, 6R) -3,3-dimethyl-6 [-2-amino-2-phenylacetamide group] -7-oxo-4-thio-1 - Amini bicyclic ring [3.2.0] heptane-2-potassium sodium salt. Molecular formula: c 16 Hide 18 N 3 Nao 4 S, molecular weight: 371.39. Ampicillin sodium is the earliest use of semi-combined penicillin antibiotics. Typical indications include: respiratory infections, hepatobiliary infections, urinary infections, skin soft tissue infections, skin soft tissue infections, suction infection, and anaerobic hyperobacteria And pelvic infection). [0004] Sulbarta soda, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/8679
Inventor 陈海刚张洁王玉娟傅超婷李富志
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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