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Method for determining content of five calcium salts in compound alpha-ketoacid tablet

A method of determination, technology of ketoacid tablets, applied in the direction of measuring devices, instruments, scientific instruments, etc.

Inactive Publication Date: 2014-10-15
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, Yang Dan et al reported in "Journal of Shenyang Pharmaceutical University", 2011, Volume 28, Issue 4 that the content of calcium ketoleucine calcium and related substances were determined by reversed-phase ion-pair chromatography. However, this document also pointed out that ion Chromatography has the inherent disadvantages that the chromatographic system is not easy to balance and the chromatographic reproducibility is poor

Method used

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  • Method for determining content of five calcium salts in compound alpha-ketoacid tablet
  • Method for determining content of five calcium salts in compound alpha-ketoacid tablet
  • Method for determining content of five calcium salts in compound alpha-ketoacid tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment one isocratic elution method

Embodiment 1-1

[0048] Chromatographic conditions:

[0049] High performance liquid chromatography: waters 2469

[0050] Detector: UV detector Detection wavelength: 210 nm

[0051] Injection volume: 20.0μl Column temperature: 30 ℃

[0052] Flow rate: 1.0 ml / min Column: Agilent C18, 5μm, 4.6×250 mm

[0053] Analytical balance: 1 / 100,000, Sartorius BS21S

[0054] Mobile phase: H 3 PO 4 Aqueous solution (pH 2.0±0.05): acetonitrile=98:2

[0055] operate:

[0056] Preparation of reference solution:

[0057] Take about 0.430g of α-ketovaline calcium, about 0.335g of α-ketoisoleucine calcium, about 0.505g of α-ketoleucine calcium, about 0.295g of α-hydroxymethionine calcium, and α-ketophenylalanine Calcium acid is about 0.340 g, and the above reference substances are calculated as dry products, accurately weighed, placed in a 100ml measuring bottle, added water and ultrasonicated for 15 minutes to dissolve, set the volume to the marked line, and shake well. Precisely pipette 5ml of the abov...

Embodiment 1-2

[0067] Chromatographic conditions:

[0068] High performance liquid chromatography: waters 2469

[0069] Detector: UV detector Detection wavelength: 210 nm

[0070] Injection volume: 20.0μl Column temperature: 30 ℃

[0071] Flow rate: 1.0 ml / min Column: Agilent C18, 5μm, 4.6×250 mm

[0072] Analytical balance: 1 / 100,000, Sartorius BS21S

[0073] Mobile phase: 0.2mol / L KH 2 PO 4 —H 3 PO 4 Aqueous solution (pH 2.5±0.05): acetonitrile = 94:6

[0074] Operation: preparation and determination method of reference substance solution and test solution: reference example 1-1.

[0075] Test results: As shown in Figure 2, the relevant data are listed in the table below.

[0076] serial number name Retention time (minutes) Calculated content (%) 1 Calcium Ketovaline 7.241 99.5 2 calcium hydroxymethionine 14.459 99.4 3 Calcium Ketoisoleucine 16.079 101.4 4 Calcium Ketoleucine 19.910 99.1 5 calcium ketophenylalanine 33.205 98....

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Abstract

The invention provides a method for determining content of five calcium salts in a compound alpha-ketoacid tablet. According to the method, a reversed phase chromatographic column taking octadecylsilyl bonded silica as a filler is employed, the detection wavelength is 205-220 nm, a mobile phase is composed of an A phase and a B phase, the A mobile phase is an aqueous solution with pH of 2.0-4.0, the B mobile phase is acetonitrile, the volume ratio of the A mobile phase to the B mobile phase is 85:15-99:1, and pH of the A phase is adjusted by an acid or a buffer salt.

Description

Technical field: [0001] The invention relates to the contents of α-ketovaline calcium, α-ketoisoleucine calcium, α-ketoleucine calcium, α-hydroxymethionine calcium and α-ketophenylalanine calcium in compound α-ketoacid tablets method of measurement. Background technique: [0002] Compound α-ketoacid tablets were first launched in Germany by Fresenius Kabi in 1996. It is clinically used for the nutrition of patients with chronic renal failure, prevention and treatment of damage caused by protein metabolism disorders caused by chronic renal insufficiency . This product contains five calcium salts (α-ketovaline calcium, α-ketoisoleucine calcium, α-ketoleucine calcium, α-hydroxymethionine calcium and α-ketophenylalanine calcium) and A compound preparation of 5 essential amino acids (L-lysine acetate, L-threonine, L-tryptophan, L-histidine, L-tyrosine). [0003] There are few literature reports on the determination methods of the five calcium salts in compound α-ketoacid tab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
Inventor 郭志强王宏玲
Owner TIANJIN JINYAO GRP
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