Analysis of Potassium Bicarbonate and Potassium Chloride Effervescent Tablets for Oral Solution According to USP-NF Method (YK-421)

The monograph below became official on August 1, 2022.

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)*), "ASSAY Procedure 1: Potassium" for "Potassium Bicarbonate and Potassium Chloride Effervescent Tablets for Oral Solution" should be carried out with a column filled with L76 packing material. The IC YK-421, a column filled with L76 packing material, confirmed the requirements were met.

System suitability requirementsResolution between potassium and magnesium ions (System suitability solution): ≥ 3.0
Tailing factor (Standard solution): ≤ 2.0
Relative standard deviation (RSD) (Standard solution): ≤ 2.0%

*The version at the time of the application acquisition.

Sample: 20 µL
(System suitability solution) 30 µg/mL of Potassium chloride and 15 µg/mL of magnesium in water

  1.  
Chromatogram of indigestible dextrin

Sample: 20 µL
(Standard solution) 30 µg/mL of Potassium chloride in water

  1.  
Chromatogram of indigestible dextrin
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 ℃

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