Capillary electrophoresis in parenteral nutrition control - validation of two analytical methods: Amino...

Production of parenteral nutrition bags (PNBs) involves many nutrients: complete control of the production process decreases the risk of error. This study aimed to develop and validate two analytical methods by capillary electrophoresis (CE) for simultaneous detection of: glucose, amino acids (Primene^®) and glucose-1-phosphate (Phocytan^®) (anionic method, AM) on one hand; and on the other hand potassium, sodium, calcium and magnesium (cationic method, CM).

Methods were developed using capillary electrophoresis with diode array detection (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). These methods were validated according to guidelines from the Société Française des Sciences et Techniques Pharmaceutiques (SFSTP).Analytical parameters were optimised: temperature was regulated at 15°C and the current settled to - 15kV, for a 21 minute 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), Repeatability and Reproducibility Coefficient of Variation (respectively RaCV and RoCV) were calculated.Capability was also calculated for each nutrient and concentration range according to guidelines from the Evaluation and Research Group on Protection in a Controlled Atmosphere (GERPAC).

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 glucose-1-phosphate (90%). Acceptance limits were settled to ±1 0% of target value. Capabilities are defined as "good" or "very good".

The methods developed by this research will ensure the composition of PNB is compliant to PNB formulas. These results show CE is an appropriate method for PNB quantitative control.CE utilisation for controlling other hospital preparations seems to be a relevant alternative to conventional methods such as liquid chromatography.