DEVELOPMENT AND VALIDATION OF A SIMULTANEOUS HPLC METHOD FOR DETERMINING THE QUANTITY OF SORBITOL, SODIUM CITRATE DIHYDRATE AND CHLORIDES IN THE MEDICINE «OROKS»

Аннотация

In this study, the amounts of sorbitol, sodium citrate dihydrate, and chlorides in the rehydration solutions were determined using a rapid, simultaneous high-performance liquid chromatography (HPLC) method. To ensure efficient separation of the active substances contained in «Oroks», a 0,1% orthophosphoric acid solution, a ShimPack SCR-102 (H) column, 8,0 mm x 300 mm, 7 μm, and a UV detector were used as the mobile phase. With this column, the separation of the drugs contained in the test solution was achieved in approximately 20 minutes. The maximum retention time for chlorides was 9,16 minutes, for sodium citrate dihydrate - about 11,26 minutes, and for sorbitol – 12,96 minutes. Retention times are provided as a guide only and may vary slightly depending on the characteristics of the system and column. It is also necessary to maintain the flow rate up to 0,3 ml/min until the condition of the chromatographic column and the thermostat reach the same standard. Before performing the next analysis, it is necessary to ensure that the flow rate in the pump is maintained at 0,3 ml/min. The proposed methods were verified for compliance with ICH requirements and evaluated using the latest software for the assessment of environmental friendliness Analytical GREEnness Indicator (AGREE). The developed method for the simultaneous determination and quantification of sorbitol, sodium citrate dihydrate and chlorides was found to be accurate, linear, precision, specific and environmentally friendly.