ABSTRACT

A novel approach was used to develop and validate a rapid, specific, accurate and precise highperformance liquid chromatographic (HPLC-RID) method for the estimation of dextrose in citrate phosphate dextrose adenine (CPDA) anticoagulant solution. Literature reveals different methods for the estimation of dextrose in bulk and their formulations. But there is no HPLC-RID method for the estimation of Dextrose in Citrate-Phosphate-Adenine-Dextrose (CPDA) anticoagulant solution. Hence the present plan of work is to develop a new, simple, precise & accurate method for dextrose analysis in bulk and formulation. The chromatographic separation was developed and validated on C18 column -7.8mm x 30-cm;9 µm. Degassed water was used as mobile phase. The flow rate was adjusted to 0.3 ml/min, column oven temperature 85°C and the detector cell temperature was adjusted 85°C by using refractive index detector. The retention time of dextrose was kept 30 minutes and dextrose was eluted at 20.333 minutes. The developed method offers excellent linearity in wide concentration range of (23 mg/mL – 35 mg/mL) for dextrose with r2 0.9989. Limit of detection (LOD) and limit of quantification (LOQ) for five analytes were 6.3 mg/mL and 19.1 mg/mL respectively. HPLC-RID method showed very good repeatability (RSD <5 %) and reproducibility. The developed method was successfully applied for quantification of dextrose in CPDA anticoagulant solution. The mean % recovery was achieved at 100.81%w/v. Robustness was performed by deliberate changes in chromatographic conditions and method was found to be robust. The proposed method was validated for specificity, accuracy, precision, linearity, range, ruggedness & robustness and can be applicable for routine quantitative analysis of dextrose in citrate-phosphate-dextrose -adenine anticoagulant solution. Keywords: HPLC-RID, ICH guidelines, method validation, Dextrose, CPDA- Citrate Phosphate Dextrose Adenine
Publication date: 01/11/2021

https://ijbpas.com/pdf/2021/November/MS_IJBPAS_2021_57446.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.11.57446