Quinidine Gluconate Injection
»Quinidine Gluconate Injection is a sterile solution of Quinidine Gluconate in Water for Injection.It contains,in each mL,amounts of quinidine gluconate and dihydroquinidine gluconate totaling not less than 76mg and not more than 84mg of quinidine gluconate,calculated as C20H24N2O2·C6H12O7.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification—
A: A1in 150solution of Injection in dilute sulfuric acid (1in 350)exhibits a vivid blue fluorescence.On the addition of a few drops of hydrochloric acid,the fluorescence disappears.
B: Asolution of Injection (1in 4)is dextrorotatory.
C: In the test for Chromatographic purity,the RFvalue of the principal spot obtained from the Test preparationcorresponds to that from the Standard preparation.
Bacterial endotoxins á85ñ— It contains not more than 0.6USP Endotoxin Unit per mg of quinidine gluconate.
Chromatographic purity— Mix an accurately measured volume of Injection,equivalent to 80mg of quinidine gluconate,with 25mLof water,add 2drops of 2Nsulfuric acid,and extract with 50mLof ether,discarding the ether extract.To the aqueous solution add 2mLof 1Nsodium hydroxide,extract with 50mLof ether,wash the extract with 25mLof water,and discard the aqueous solutions.Evaporate the ether extract just to dryness,and dissolve the residue in 10mLof alcohol.Using this as the test solution,proceed as directed in the test for Chromatographic purityunder Quinidine Gluconate,beginning with “Apply 10-µLportions of the Test preparation.”
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Methanesulfonic acid solution ,Diethylamine solution,Mobile phase,System suitability preparation,and System suitability test—Proceed as directed in the test for Limit of dihydroquinidine gluconateunder Quinidine Gluconate.
Standard preparation— Transfer about 26mg of USP Quinidine Gluconate RS,accurately weighed,to a 100-mLvolumetric flask,dissolve in and dilute with Mobile phaseto volume,and mix.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 400mg of quinidine gluconate,to a 50-mLvolumetric flask,add methanol to volume,and mix.Transfer 3.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure (see Chromatography á621ñ)—Inject equal volumes (about 50µL)of the Standard preparationand the Assay preparationinto a chromatograph equipped with a 235-nm detector and a 3.9-mm ×30-cm column that contains packing L1.Calculate the quantity,in mg,of the Sum of quinidine gluconate and dihydroquinidine gluconatein each mLof the Injection taken by the formula:
(5000/3)(C/V)(rb,U+rd,U)/(rb,S+rd,S),
in which Cis the concentration,in mg per mL,of USP Quinidine Gluconate RSin the Standard preparation,Vis the volume,in mL,of Injection taken,rb,Uand rb,Sare the peak responses of quinidine obtained from the Assay preparationand the Standard preparation,respectively,and rd,Uand rd,Sare the peak responses of dihydroquinidine obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1693
Phone Number:1-301-816-8305