Capillary electrophoresis in parenteral nutrition control – Validation of two analytical method: Amino acids/Glucose/Glucose-1-Phosphate and Ka/Na/Ca/Mg

Context
Production of parenteral nutrition bags (PNB) involve many nutrients. Exhaustive control of these components decreases the risk of error.

Purpose
The aim of this study was to develop and validate 2 analytical methods by capillary electrophoresis (CE) for simultaneous detection of: amino acids (Primene®), glucose and glucose-1-phosphate (Phocytan^®) on one hand (anionic method, AM), potassium, sodium, calcium and magnesium on the other hand (cationic method, CM).

Materials et Method
Methods were developed using CE-DAD (CE 7100, Agilent^®), indirect photometric detection, 56 cm long capillary and two different buffers (pH = 12,1 for AM and pH = 3,2 for CM).
They were validated according to the SFSTP guidelines with concentration ranges allowing validation of HAS standard nutrition bags.
Analytical parameters were optimized: temperature was regulated at 15°C and current settled to – 15kV, for a 21 minutes analysis time for AM. Conditions were settled to 25°C and 30kV for CM so the analysis time dropped to 7 minutes.
Accuracy profiles were established and recovery rates (RR), Repetability and Reproductibility Coefficient of Variation (respectively RaCV and RoCV) were calculated.
Capability was also calculated for each nutrient and concentration range as per the Groupe d’Evaluation et de Recherche sur la Protection en Atmosphère Contrôlée (GERPAC) guidelines.

Results
Methods were successfully validated with: RR between 99,2 and 101,9%, RaCV between 1,5 and 3,1%, and RoCV between 2,4 and 4,1% for AM; and RR between 97,5 and 102,7%, RaCV between 0,5 and 2,3%, and RoCV between 0,6 and 2,8% for CM.
Accuracy profiles were established with 95% β probability, except for Phocytan^® (90%). Acceptation limits were settled to ± 10% of target value.
Capabilities are defined as “good” or “very good” as per GERPAC guidelines.

Discussion-Conclusion
Developing these methods ensures the composition of PNB is compliant. These results show CE is an appropriate method for PNB quantitative control.
CE utilisation for controlling others hospital preparations seems to be a relevant alternative to conventional methods such as liquid chromatography.

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