Analytical Method Development and Validation for the Estimation of Dextrose in Citrate Phosphate Dextrose Anticoagulant Solution by HPLC-RID Abhijith R. R.1,*, Gopalakrishnan G.2, Kingsley R. Bino3 1Quality Control Department, Terumo Penpol Private Limited, Puliyarakonam PO, Thiruvananthapuram - 695573, Kerala, India. 2Department of Pharmacy, Annamalai University, Tamil Nadu. 3Department of Pharmacy, Elims college of Pharmacy, Tirussur, Kerala. *Corresponding Author E-mail: rra@live.in
Online Published on 06 March, 2023. Abstract HPLC-RID developed a simple, accurate, precise, linear, rugged, and robust method for quantifying dextrose in Citrate Phosphate Dextrose (CPD) anticoagulant solution. Despite the fact that there are techniques for simultaneous estimation of dextrose and phosphate by RP-HPLC and measurement of sugars and polyols by HPLC-RID, there was no methods in the literature for measuring Dextrose in Citrate Phosphate Dextrose (CPD) anticoagulant solutions. The current work designed and validated a simple HPLC-RID technique using the C18 column (7.8mm × 30cm × 9μm) with degassed water as the mobile phase. Using a refractive index detector, the flow rate was adjusted to 0.3 mL/min, the column oven temperature was at 85°C, and the detector cell temperature was set to 85°C. The dextrose run time was set to 30 min, and the dextrose was eluted at 20.294 min. The developed method has excellent linearity for dextrose in a wide concentration range (18.6mg/mL – 27.8mg/mL) with an R2 of 0.9981. For five analytes, the limits of detection (LOD) and limits of quantification (LOQ) were 3.9mg/mL and 11.9mg/mL, respectively. The HPLC-RID method demonstrated excellent repeatability (RSD 5%) and reproducibility. Changes in chromatographic conditions were used to test robustness. Even when subjected to modest changes in regular analysis, the technique was shown to be resilient and useful. Specificity, accuracy, precision, linearity, range, ruggedness, and robustness were all validated for the proposed method. The developed method has the potential to be used for quantitative analysis of dextrose in anticoagulant solutions. Top Keywords HPLC-RID, ICH guidelines, Dextrose, CPD-Citrate Phosphate Dextrose anticoagulant solution. Top |