Colistin Sulfate
»Colistin Sulfate is the sulfate salt of an antibacterial substance produced by the growth of Bacillus polymyxavar.colistinus.It has a potency equivalent to not less than 500µg of colistin per mg.
Packaging and storage
Preserve in tight containers.
Identification
A:
Dissolve about 20mg in 2mLof buffer solution,prepared by adjusting 50mLof 1Mmonobasic potassium phosphate with 1Nsodium hydroxide to a pHof 7.0,diluting with water to 100mL,and mixing.Add 0.2mLof ninhydrin solution (1in 200)and boil:a purple color is produced.
B:
It meets the requirements of the tests for Sulfate á191ñ.
C:
Liquid Chromatographic Identification Test
Mobile phase
Prepare a mixture of 0.1Mtribasic sodium phosphate and acetonitrile (77:23),and adjust with phosphoric acid to a pHof 3.0.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard solution
Prepare a solution of USP Colistin Sulfate RSin Mobile phasehaving a concentration of about 6mg per mL.Protect this solution from light.
Test solution
Prepare a solution of Colistin Sulfate in Mobile phasehaving a concentration of about 6mg per mL.Protect this solution from light.
Chromatographic system (see Chromatography á621ñ)
The liquid chromatograph is equipped with a 212-nm detector and a 4.6-mm ×25-cm column that contains 5-µm packing L1.The flow rate is about 1mLper minute.
Procedure
Separately inject equal volumes (about 10µL)of the Standard solution and the Test solutioninto the chromatograph,and record the chromatograms.The chromatogram obtained from the Test solutioncorresponds qualitatively with that obtained from the Standard solution,exhibiting a major peak corresponding to colistin Aand minor peaks at relative retention times of about 0.55(colistin B)and 0.8.
pHá791ñ:
between 4.0and 7.0,in a solution containing 10mg per mL.
Loss on drying á731ñ
Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 7.0%of its weight.
Assay
Proceed as directed for Colistin under AntibioticsMicrobial Assays á81ñ.
Auxiliary Information
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28NF23Page 541
Pharmacopeial Forum:Volume No.28(4)Page 1093
Phone Number:1-301-816-8335
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