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Method for determining content of benzalkonium chloride in salmon calcitonin nasal spray by HPLC method

A salmon calcitonin and benzalkonium chloride technology, applied in the field of analytical chemistry, can solve the problems of easy tailing of chromatographic peaks, difficulty in accurate quantification, large tailing factor, etc., and achieves good durability, high sensitivity, and tailing. The effect of a small factor

Pending Publication Date: 2019-07-19
YINGU PHARMA
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Problems solved by technology

[0004] Benzalkonium chloride is a quaternary ammonium compound, the chromatographic peaks are easily tailed, and the peak shape is poor, which causes certain difficulties for accurate quantification
The current 2015 edition of the Chinese Pharmacopoeia Neomycin Sulfate Eye Drops and Tobramycin Eye Drops quality standards involves the detection of the preservative benzalkonium chloride, but the tailing factors are relatively large (about 1.5)

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  • Method for determining content of benzalkonium chloride in salmon calcitonin nasal spray by HPLC method
  • Method for determining content of benzalkonium chloride in salmon calcitonin nasal spray by HPLC method
  • Method for determining content of benzalkonium chloride in salmon calcitonin nasal spray by HPLC method

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Embodiment 1

[0051]Example 1 The method for HPLC determination of benzalkonium chloride content in salmon calcitonin nasal spray

[0052] Chromatographic conditions:

[0053] Chromatographic column: C18 (4.6×250mm, 5μm, 12nm), YMC, model: TA12S05-2546WT

[0054] Mobile phase: mobile phase A is 10mmol / L ammonium acetate aqueous solution, add 1.5% triethylamine, adjust pH to 5.0±0.5 with glacial acetic acid; mobile phase B is acetonitrile; A:B=30:70 (volume ratio, v / v), isocratic elution.

[0055] Flow rate: 1.0mL / min;

[0056] Detection wavelength: 262nm;

[0057] Column temperature: 40°C;

[0058] Injection volume: 20 μl.

[0059] Take 20 μl of system suitability solution and inject it into the liquid chromatograph, the separation degree of benzalkonium chloride C12 peak and C14 peak should meet the requirements, the separation degree of benzalkonium chloride C12 peak and salmon calcitonin peak should be greater than 1.5, according to benzalkonium chloride For ammonium chloride C12 ...

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Abstract

The invention belongs to the field of analytical chemistry, and relates to a method for determining the content of benzalkonium chloride in a salmon calcitonin nasal spray by an HPLC method. A chromatographic column adopted in the method adopts octadecyl silane chemically bonded silica as filler, and an optimized mobile phase A and a mobile phase B are adopted for isocratic elution; and a drug isa polypeptide nasal spray, and a bacteriostatic agent is benzalkonium chloride. According to the method, the content of the bacteriostatic agent in the salmon calcitonin nasal spray of polypeptide drugs can be conveniently and accurately determined; and the method is easy and convenient to operate, rapid, accurate, high in sensitivity, good in repeatability, mild in condition and small in trailingfactor, through systematic methodology verification, it is proved that the method is applied to the determination of the content of the benzalkonium chloride in the salmon calcitonin nasal spray, theinspection results are accurate and reliable, and great significance to the quality control of the salmon calcitonin nasal spray is achieved.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for analyzing and measuring the content of benzalkonium chloride in salmon calcitonin nasal spray by HPLC. Background technique [0002] Salmon calcitonin nasal spray is used to treat diseases such as osteoporosis, Paget's disease (osteitis deformans), hypercalcemia, hypercalcemia crisis and various bone pains, and has achieved good results for more than ten years. Because of its remarkable curative effect and small side effects, it has been well received by medical workers and patients. [0003] Salmon calcitonin nasal spray is an aqueous solution, and benzalkonium chloride is its antibacterial agent, which can inhibit the growth of bacteria, thereby prolonging the storage period of the drug and ensuring the safety of patients during use. The benzalkonium chloride contained in the prescription of this product is a commonly used bacteriostatic agent. If i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 潘缘媛孟永刚杨雪
Owner YINGU PHARMA
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