Determination of Potassium Citrate and Sodium Citrate Chewable Tablets Content and Related Substances by RP-HPLC

作者：Luo, L. Y.; Luo, L.; Luo, Y. H.^*; Wang, C. Y.; Jiang, C.; Chen, Q.; Luo, M.; Long, F.; Wang, S.; Tan, M. G.; Chen, D.

来源：Latin American Journal of Pharmacy, 2013, 32(1): 37-42.

• Chewable tablets
• Citrate
• Content
• Related substances
• RP-HPLC

The aim of the present study was to determinate the potassium citrate, sodium citrate, and related substances content in chewable tablets. To fulfill this purpose, a high performance liquid chromatography (HPLC) method was established. The separation was performed on a VP-ODS C-18 column (4.6 mm x 250 mm, 4.6 mu m). The mobile phase consisted of 0.5% ammonium sodium phosphate (adjusted to pH3.0 +/- 0.05 with 85% phosphoric acid) - methanol (97.5:2.5) and the flow rate was 1.0 mL/min. The detection wavelength was 210 nm and the column temperature was 30 degrees C. Related substances and degraded substances were completely separated from citrate. The linear range of determination was from 2.5 to 40 mmol/L with the correlation coefficient of 0.9999. The average recoveries (n = 9) was 100.24% (RSD = 0.26%). The precision (RSD = 0.14%) and repeatability (RSD = 1.3%) for method were good. Sample solutions were basically stable within 24 h (RSD = 0.61%). The LOD was 0.8 mu g/mL, and LOQ was 3 mu g/mL. The RP-HPLC method is simple, rapid, accurate, sensitive and suitable for the determination of the content and related substances of potassium citrate and sodium citrate chewable tablets.

• 出版日期2013
• 单位西南大学