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Determination method of norfloxacin content in norfloxacin capsule

A norfloxacin and determination method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of poor uniformity of measurement results, insufficient sample dissolution, inaccurate detection results, etc., and achieve convenient and accurate preparation The effect of high precision and accurate measurement results

Inactive Publication Date: 2019-04-19
WUHAN TONGJI MODERN PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] According to the recommendation of ChP2015, the HPLC method can be used to detect the content of norfloxacin in norfloxacin capsules in actual clinical practice. Soluble, slightly soluble in chloroform, almost insoluble in water and methanol, its solubility in water is only 0.3mg / ml, and the solubility of norfloxacin in 0.1M hydrochloric acid solution is 32mg / ml, so ChP2015 provides Both the test sample and the reference substance were dissolved in 0.1M HCL solution. After actual operation, we unexpectedly found that the extraction of norfloxacin capsules in 0.1M HCL solution was not complete, and the capsule shell was easily stuck in 0.1M HCL solution, resulting in The content is aggregated into agglomerates, and the sample is not fully dissolved during the specific operation, which leads to deviations in the measurement results, and the uniformity of the measurement results is not good, resulting in inaccurate test results

Method used

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  • Determination method of norfloxacin content in norfloxacin capsule
  • Determination method of norfloxacin content in norfloxacin capsule
  • Determination method of norfloxacin content in norfloxacin capsule

Examples

Experimental program
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Effect test

Embodiment 1

[0028] A method for measuring the content of norfloxacin in norfloxacin capsules of the present embodiment comprises the following steps:

[0029] (1) Preparation of reference substance solution: Precisely weigh 25 mg of norfloxacin reference substance in a 100ml volumetric flask, dissolve and dilute to the mark with 0.025mol / L phosphoric acid solution: acetonitrile (87:13) solvent, shake well, As norfloxacin reference substance solution stock solution; dilute the above reference substance solution stock solution step by step into a solution with norfloxacin concentration of 10, 20, 25, 50, 100 μg / ml, and shake well.

[0030] (2) Preparation of the test solution: take the contents of 20 norfloxacin capsules, grind and mix for 1 min, accurately weigh an appropriate amount (equivalent to about 25 mg of norfloxacin), accurately weigh, and place in a 100ml volumetric flask , add 0.025mol / L phosphoric acid solution: acetonitrile (87:13) solvent to dissolve and dilute to the mark by...

Embodiment 2

[0039] A method for measuring the content of norfloxacin in norfloxacin capsules of the present embodiment comprises the following steps:

[0040] (1) Preparation of reference substance solution: Precisely weigh 25mg of norfloxacin reference substance in a 100ml volumetric flask, add 2ml of 0.1mol / L hydrochloric acid solution to dissolve, dilute with water to the mark, and shake up; The stock solution was gradually diluted into a solution with a concentration of norfloxacin of 10, 20, 25, 50, 100 μg / ml, and shaken well.

[0041] (2) Preparation of the test solution: take 20 norfloxacin capsules, take the fine powder of the contents, accurately weigh an appropriate amount (equivalent to about 25 mg of norfloxacin), accurately weigh it, and place it in a 100ml volumetric flask, Add 2ml of 0.1mol / L hydrochloric acid solution to dissolve, dilute to the mark with water, shake well, accurately measure 5ml, put it in a 50ml measuring bottle, dilute to the mark with mobile phase, shak...

Embodiment 3

[0055] Weigh a batch of 9 parts of the reference preparation (approximately equivalent to 25mg of norfloxacin), a group of 3 parts, add a certain amount of norfloxacin reference substance solution respectively, and prepare the sample solution according to the method in Example 1. Repeat 3 times to get the average value and calculate the recovery rate. The results are shown in Table 3.

[0056] Recovery %=(measured amount of norfloxacin-amount of norfloxacin in the sample) / amount of added norfloxacin×100%.

[0057] Same as above, take a batch of 9 parts of the reference preparation, a group of 3 parts, add a certain amount of norfloxacin reference substance solution respectively, prepare the sample solution according to the method in Example 2, repeat each level 3 times to get the average value, calculate The recovery rate, the results are shown in Table 4.

[0058] It can be seen from the above Table 3 that the determination result of the present invention obtained after the ...

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Abstract

The invention relates to a determination method of norfloxacin content in a norfloxacin capsule, belongs to the field of drug analysis. The determination method comprises development and verificationof an analysis method. The determination method comprises the following specific steps: when a test sample solution is prepared, dissolving and diluting with a solvent comprising 0.025M phosphoric acid solution and acetonitrile (with the ratio of 87: 13). Compared with a ChP2015 pharmacopoeia method, the method provided by the invention has the advantages that content detection is carried out on aself-made sample and two batches of reference preparations, and results show that the content of the two batches of reference preparations and the self-made sample is higher in detection accuracy, the sample is more fully dissolved, and the uniformity of the determination results is good.

Description

technical field [0001] The invention belongs to the field of drug analysis, and more specifically, the invention relates to a method for determining the content of norfloxacin in norfloxacin capsules. Background technique [0002] Norfloxacin (Norfloxacin, also known as Nornxin, Fulgram), aliases: Li alcohol Luo, norfloxacin, Lin Kexing. Its chemical name is 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. This product is a third-generation quinolone antibacterial drug, which can hinder the action of DNA gyrase (DNA Gyrase) of pathogenic bacteria in the digestive tract, hinder bacterial DNA replication, and have an inhibitory effect on bacteria. It is a commonly used medicine for the treatment of enteritis and dysentery. Norfloxacin capsules are suitable for urinary tract infections, gonorrhea, prostatitis, intestinal infections and typhoid and other Salmonella infections caused by sensitive bacteria. [0003] The structure of norfloxacin i...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 李亦武
Owner WUHAN TONGJI MODERN PHARMA TECH CO LTD
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