According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 45(5)*), sodium bicarbonate and potassium bicarbonate 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, and meets following requirements. The use of a cation column, IC YK-421, confirmed the requirements were met.
System suitability requirements:
Resolution of sodium and ammonium ions (in system suitability solution): ≥ 2.0
Tailing factor of potassium and sodium ions (in standard solution): ≤ 2.0%
Relative standard deviation (RSD): ≤ 2.0%
*The version at the time of the application acquisition.
Sample : 20 μL
(System suitability solution)
30 µg/mL each of Sodium bicarbonate and Ammonium chloride in H2O
Sample : 20 μL
(Standard solution)
10 µg/mL of Potassium bicarbonate and 30 µg/mL of Sodium bicarbonate 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
