Potassium Gluconate and Potassium Citrate Oral Solution
»Potassium Gluconate and Potassium Citrate Oral Solution is a solution of Potassium Gluconate and Potassium Citrate in a suitable aqueous medium.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of potassium (K).
Packaging and storage— Preserve in tight containers.
Labeling— Label it to state the potassium content in terms of milliequivalents in a given volume of Oral Solution.
Identification—
A: To 2mLof a dilution of Oral Solution (1in 40)add 5mLof sodium cobaltinitrite TS:a yellow precipitate is formed immediately (presence of potassium).
B: It responds to the test for Citrate á191ñ,3to 5drops of Oral Solution and 20mLof the mixture of pyridine and acetic anhydride being used.
Assay for potassium—
Potassium stock solution— Dissolve in water 0.9535g of potassium chloride,previously dried at 105for 2hours.Transfer to a 500-mLvolumetric flask,dilute with water to volume,and mix.This solution contains 1000µg of potassium per mL.
Standard preparations— To separate 200-mLvolumetric flasks transfer 19.0mLand 25.0mL,respectively,of Potassium stock solution,dilute with water to volume,and mix.The Standard preparationscontain 95.0µg and 125.0µg of potassium per mL,respectively.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 782mg (20mEq)of potassium,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 7.0mLof this solution to a 500-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Concomitantly determine the absorbances of the Standard preparationsand the Assay preparationat the resonance line of 766.5nm,with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering á851ñ)equipped with a potassium hollow-cathode lamp and an air–acetylene flame,using water as the blank.Plot the absorbances of the Standard preparationsversus concentration,in µg per mL,of potassium.From the graph so obtained,determine the concentration,C,in µg per mL,of potassium in the Assay preparation.Calculate the quantity,in mg,of potassium in each mLof the Oral Solution taken by the formula:
(50/7)(C/V),
in which Vis the volume,in mL,of Oral Solution taken.Each mg of potassium is equivalent to 0.02558mEq.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1594
Phone Number:1-301-816-8379