Abstract
A multiparametric flow system based on multicommutation and binary sampling has been designed for the automated determination of sodium, potassium, calcium, and magnesium in large-volume parenteral solutions and hemodialysis concentrated solutions. The goal was to obtain a computer-controlled system capable of determining the four metals without extensive modifications. The system involved the use of five solenoid valves under software control, allowing the establishment of the appropriate flow conditions for each analyte, that is, sample size, dilution, reagent addition, and so forth. Detection was carried out by either flame atomic emission spectrometry (sodium, potassium) or flame atomic absorption spectrometry (calcium, magnesium). The influence of several operating parameters was studied. Validation was carried out by analyzing artificial samples. Figures of merit obtained include linearity, accuracy, precision, and sampling frequency. Linearity was satisfactory: sodium, (– g/L), potassium, (50–150 mg/L), calcium, (30–120 mg/L), and magnesium, (20–40 mg/L). Precision (, %, ) was better than %, and accuracy (evaluated through recovery assays) was in the range of %–% (sodium), –% (potassium), %–% (calcium), and %–% (magnesium). Sampling frequencies () were 70 (sodium), 75 (potassium), 70 (calcium), and 58 (magnesium). According to the results obtained, the use of an automated multiparametric system based on multicommutation offers several advantages for the quality control of large-volume parenteral solutions and hemodialysis concentrated solutions.
Highlights
Large-volume parenteral solutions are injections widely used in hospitals for treatment of a wide array of conditions
The work presented in this paper refers to the design and evaluation of an automated multiparametric system based on multicommutated flow analysis for the determination of sodium, potassium, calcium, and magnesium
Synthetic samples of several formulations were prepared by exact weighing and dilution of each of the ingredients. These formulations were representative of several large-volume parenteral solutions and concentrate hemodialysis solutions found both in the United States Pharmacopeia (USP) and in the market: (i) Ringer’s injection (USP); (ii) lactated ringer’s and dextrose injection (USP); (iii) hemodialysis concentrated solution with dextrose; (iv) acidic hemodialysis concentrated solution with dextrose
Summary
Large-volume parenteral solutions are injections widely used in hospitals for treatment of a wide array of conditions. Hemodialysis concentrated solutions are qualitatively similar in composition to large-volume parenterals but the concentration of the salts is higher They should be carefully diluted before use to obtain the final solutions. Flow techniques such as flow-injection analysis [4,5,6] are being used increasingly in quality control in the pharmaceutical laboratory. Flow-injection analysis has been used successfully for the automation of the determination of sodium, potassium, calcium, and magnesium in parenteral solutions [7]. The work presented in this paper refers to the design and evaluation of an automated multiparametric system based on multicommutated flow analysis for the determination of sodium, potassium, calcium, and magnesium
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