What Is Clindamycin Hydrochloride?

Antibiotics. It is a derivative of lincomycin and has been on the market in China since 1970. The antibacterial spectrum is the same as lincomycin, but it has a strong antibacterial effect. It is mainly used clinically for osteomyelitis, anaerobic infections, respiratory infections, biliary infections, endocarditis, otitis media, skin and soft tissue infections, and sepsis. The most common adverse reactions in the application: allergic reactions, local injection irritation and abnormal liver function, and the most serious is pseudomembranous enteritis (PMC).

Clindamycin hydrochloride

Antibiotics. It is a derivative of lincomycin and has been on the market in China since 1970.

Clindamycin hydrochloride (alias: clindamycin,

1 Gastrointestinal reactions, stomach upset, nausea, vomiting, etc., a few can occur

Pregnancy class C. Pregnant and lactating women, severe liver

Method name: Determination of clindamycin hydrochloride-high performance liquid chromatography

Application: This method uses high performance liquid chromatography to determine the content of clindamycin hydrochloride (C18H33ClN2O5S · HCl).

This method is applicable to clindamycin hydrochloride.

Principle of the method: The test product is made into a mobile phase solution, which is subjected to chromatographic separation by high-performance liquid chromatography. The absorption value of clindamycin hydrochloride is measured at a wavelength of 210 nm with an ultraviolet absorption detector, and the content is calculated.

Reagents: 1. Potassium dihydrogen phosphate solution

Acetonitrile

Equipment: 1. Instrument

1.1 HPLC

1.2 Column

Octadecylsilane-bonded silica gel is used as a filler, and the theoretical plate number should not be lower than 1300 calculated by the clindamycin peak.

1.3 UV absorption detector

Chromatographic conditions

2.1 Mobile phase: potassium dihydrogen phosphate solution: acetonitrile = 55: 45

2.2 Detection wavelength: 210nm

2.3 Column temperature: room temperature

Sample preparation: 1. Mobile phase

Take 6.8 g of potassium dihydrogen phosphate, dissolve and dilute with water to make 1000 mL, adjust the pH value to 7.5 with 25% potassium hydroxide solution to obtain potassium dihydrogen phosphate solution, and mix with acetonitrile at an equal ratio of 55:45.

2. Preparation of test solution

50mg of this product is accurately weighed, placed in a 50mL volumetric flask, and the mobile phase to be tested is dissolved and diluted to the mark, and shaken to obtain.

3. Preparation of reference solution

Accurately weigh the appropriate amount, add the mobile phase to dissolve and make a solution containing 1.0mg per 1mL, and shake to obtain.

4. Preparation of system suitability solution

Accurately weigh the appropriate amount of the reference substance, add the mobile phase to dissolve and make a solution containing 4.0mg per 1mL, and shake to obtain.

Note: "Precision weighing" means that the weighed weight should be accurate to one thousandth of the weight taken. "Precision measurement" means that the accuracy of measuring the volume should meet the accuracy requirements of the volume pipette in national standards.

Operation steps: Precisely draw 20 L each of the reference solution and the test solution into a high-performance liquid chromatograph, use an ultraviolet absorption detector to measure the absorption value of clindamycin at a wavelength of 210 nm, and calculate its content.

References: Pharmacopoeia of the People's Republic of China, compiled by the National Pharmacopoeia Committee, Chemical Industry Press, 2015 Edition, Part Two, p.974.