Analysis of compound chlorhexidine metronidazole suppository by liquid chromatography

This product contains chlorhexidine acetate (C22H30Cl2N10.2C2H4O2) and metronidazole (C6H9N3O3) should be 90.0% to 110.0% of the marked amount.
【Prescription】 Chlorhexidine acetate 7.50g
Metronidazole 90.0g
Camphor 3.00g
Semi-synthetic fatty acid glycerin fat Appropriate amount of paraffin Appropriate amount of anhydrous lanolin Appropriate amount of absolute ethanol Appropriate amount

Made into 1000 capsules
【Properties】 This product is a milky white suppository.
[Identification] (1) Take 1.5g of this product, add 8ml of sodium hydroxide test solution, warm dissolve to red, add 8ml of diethyl ether, shake to extract, take the ether layer (aqueous layer reserved) heated 1% bromide 5ml of alkyltrimethylamine solution, 1ml each of sodium hydroxide test solution and bromine test solution, after shaking, the aqueous solution appears red.
(2) Take the above standby water layer, add dilute hydrochloric acid to make it acidic, the solution is yellow, and add excess sodium hydroxide test solution, the solution is brownish red.
(3) Take about 3g of this product, add 10ml of ethanol, dissolve it after warming, let cool, filter, put the filtrate into a test tube, slowly add 3ml of 1% vanillin solution along the wall of the tube to form a purple-red ring .
(4) In the chromatogram recorded under the content determination item, the retention time of each main peak of the test solution should be consistent with the retention time of the main peak of the corresponding reference substance.
[Inspection] It should comply with the relevant regulations under the suppository (Chinese Pharmacopoeia 2000 edition appendix ID).
[Determination of content] According to high performance liquid chromatography (Chinese Pharmacopoeia, 2000 edition, Appendix VD).
Chromatographic conditions and system suitability tests use octadecylsilane-bonded silica gel as a filler; acetate buffer solution (take 80g of ammonium acetate, 2g of sodium octane sulfonate and 800ml of water to dissolve, adjust pH to 4.2 with glacial acetic acid , Add water to 1000ml) -methanol (40:60) as the mobile phase; detection wavelength: metronidazole 315nm, chlorhexidine acetate 260nm (after the metronidazole peak comes out, change the detection wavelength to 260nm). The number of theoretical plates calculated by metronidazole and chlorhexidine acetate should be no less than 2500
This article comes from the analysis of compound chlorhexidine metronidazole suppositories by liquid chromatography analysis | Scientific Instrument Online Original Link: http: //

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