Analysis of Potassium Bicarbonate and Potassium Chloride Effervescent Tablets for Oral Solution Proposed in USP-NF Pharmacopeial Forum (YK-421)

Potassium preparation drugs supplement potassium in the body and improve the symptoms such as weakness and nausea caused by lack of potassium.
According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 45(5)*), potassium ion assay of the potassium bicarbonate and potassium chloride effervescent tablets for oral solution should be carried out with an ion chromatography and a column filled with L76 packing material using, and meets following requirements. The use of a cation column, IC YK-421, confirmed the requirements were met.

System suitability requirements:
Resolution of potassium and calcium ions: ≥ 3.0
Tailing factor: ≤ 2.0%
Relative standard deviation (RSD): ≤ 2.0%

*The version at the time of the application acquisition.

Sample : 20 µL
30 µg/mL of Potassium chloride
and 15 µg/mL of Magnesium in H₂O

Sample : 20 µL
30 µg/mL of Potassium chloride in H₂O

Column       : Shodex IC YK-421 (4.6 mm I.D. x 125 mm)
Eluent       : 4 mM Nitric acid aq.
Flow rate    : 0.9 mL/min
Detector     : Non-suppressed conductivity
Column temp. : 30 °C