Determination of sodium closantel in sodium closantel injection

Program Summary:

Sodium closantel is a commonly used veterinary anti-parasitic drug. Chemical name: 2 – cyano – 3 – iodine – N-(4 – chlorophyllium – 2 – methylphenyl)-6 – trifluoromethylbenzamide sodium salt, molecular formula: C₁₉H₁₁ClF₃IN₂NaO Therapeutic effect: It is a key component of the injection to exert anti-parasitic effects. It is used to treat diseases caused by the above parasitic infections of cattle, sheep and other animals. For example, liver tablet flukesomyllium can cause damage to the liver and digestive dysfunction of animals, etc. The use of sodium closantel can effectively kill liver tablet flukesomyllium, relieve the condition, and promote the recovery of animals’ health.

Product configuration list:

LC5190 low-pressure ultra-high performance liquid chromatograph

Plan details:

Instrument configuration: LC5190 low-pressure ultra-high performance liquid chromatograph, including automatic sampler, low-pressure gradient pump, degasser, detector and column thermostat

Sodium closantel is a commonly used antiparasitic drug for veterinary use

Chemical Name: 2 – Cyano – 3 – Iodine – N-(4 – Chlorine – 2 – Methylphenyl)-6 – Trifluoromethylbenzamide Sodium Salt

Molecular formula: C₁₉H₁₁ClF₃IN₂NaO

Treatment effect: It is a key ingredient in the injection to exert its anti-parasitic effects. It is used to treat diseases caused by the above parasitic infections of cattle, sheep and other animals. For example, liver tablet flukesomiasis can cause damage to the liver and digestive dysfunction of animals, etc. The use of sodium chlorobenzoic acid sodium injection can effectively kill liver tablet flukesomiasis, alleviate the condition, and promote the recovery of animals’ health.

Preventive effect: In areas or seasons where parasite diseases are high, regular injection of sodium closantel injected into animals can prevent parasite infection and ensure the healthy growth and normal performance of animals. For example, in some sheep farms, injecting this injection before the peak of parasite breeding in spring and autumn can effectively prevent sheep from being infected with parasites such as gastrointestinal nematodes.

Quality standards: There are strict standards and specifications in terms of production and quality control. It is necessary to test the product’s appearance, content, relevant substances, dry weight loss, heavy metal content and other indicators to ensure that the product meets the quality standards of veterinary drugs. For example, the content of sodium closantel should not be less than 98.0%, and the content of relevant substances should meet the specified limits to ensure the effectiveness and safety of the drug.

When determining the content of sodium closantel in sodium closantel injection by high performance liquid chromatography, the following precautions are given:

1. Instruments and columns

Instrument performance inspection: Before use, a comprehensive performance inspection of the high-performance liquid chromatograph must be carried out, including the pump flow rate accuracy, pressure stability, detector sensitivity and baseline stability, etc. Ensure that all indicators of the instrument meet the requirements, otherwise it will affect the accuracy and precision of the measurement results.

Column selection and maintenance: According to the properties of sodium cyanosanamide, C18 columns with appropriate particle size and length are generally selected. Before use, the new column should be fully activated according to the instructions. During use, pay attention to the pH range of the mobile phase to avoid damage to the stationary phase beyond the tolerant range of the column. At the same time, it is necessary to prevent impurities such as solid particles from entering the chromatographic column, and appropriately rinse and store after each use.

2. Reagents and solutions

Reagent purity: The solvents such as acetonitrile, water, and buffer salts used should have high purity, such as chromatographic pure grade. Impurity reagents may introduce impurity peaks, interfere with the determination of sodium closantel and may also contaminate the column and instrument system.

Solution preparation

Standard solution: When preparing standard solutions, accurately weigh the sodium closantel sodium, completely dissolve it with a suitable solvent, and prepare standard solutions of different concentrations strictly according to the dilution steps. At the same time, attention should be paid to the storage conditions and validity period of the standard solution to avoid inaccurate concentration due to degradation and other reasons.

Test solution: When measuring injection, use a measuring tool with appropriate accuracy to ensure accurate measurement. Shake well during dilution to make the solution mix evenly. When filtration, select a filter membrane with the appropriate pore size, such as a filter membrane of 0.45μm to prevent the filter membrane from adsorbing or retention of drug components and affecting the measurement results.

3. Sample processing

Sample storage and transportation: Samples of sodium closantel injection should be stored and transported under specified conditions to avoid factors such as light, high temperature, and humidity that affect their stability. If the sample needs to be transported for a long distance, appropriate protective measures should be taken to ensure that the sample is in good condition when it arrives in the laboratory.

Prevent cross-contamination: During the sample processing, clean equipment should be used to avoid cross-contamination between different samples and between samples and other impurities. For example, use disposable pipette tips, sample vials, etc., and replace them in time after each use.

4. Analysis methods and operations

Method verification: Before formal measurement, the established high-performance liquid chromatography method must be comprehensively verified, including indicators such as accuracy, precision, linearity, range, detection limit, and quantitative limit. Only when the method verifies that the results meet the requirements can the reliability of the measurement results be ensured.

Injection operation: Before injection, make sure the injection needle is clean and without residues, and the injection volume must be accurate and repeatable. Avoid bubbles when injecting, otherwise it will affect the accuracy of the injection volume and the shape of the chromatographic peak.

Data processing: The data must be recorded accurately. When calculating the content according to the standard curve, pay attention to the effective numbers and calculation accuracy of the data. Reasonable statistical analysis should be carried out on the data measured multiple times, such as calculating the mean value, standard deviation, etc., to judge the reliability and precision of the data.

5. Environmental conditions

Temperature and humidity: High performance liquid chromatographs have certain requirements for ambient temperature and humidity. Generally, the temperature should be controlled at 15℃-30℃ and the relative humidity should be 45%-75%. Severe changes in temperature and humidity may affect the performance of the instrument and the separation of the column.

Cleanliness: The experimental environment should be kept clean to avoid impurities such as dust entering the instrument system, affecting the optical path system or blocking the chromatographic column.