Background: Haemodialysis is a process to remove the waste products and excess fluids
that build up in the human body when kidneys stop working. Haemodialysis concentrate consists of
two parts, acid concentrate (Part A) that contains mineral ions (Na, K, Mg and Ca) and buffering agent
acetic acid /citric acid whereas basic concentrate (Part B) comprises sodium bicarbonate alone or in
combination with sodium chloride.
Aim: Present research aimed to develop and validate a rapid method for the determination of cations
and anions in haemodialysis concentrates in solution and powder form by choosing one technique
among various suggested in ISO 13958:2014.
Methods: The analysis was done by flame emission (flame photometer), atomic absorption spectrometer
(AAS), polarimetric and titrimetric techniques. ICH guidelines were followed for method validation
by addressing the linearity, accuracy, precision and detection limits (LOD and LOQ).
Results and Discussion: The calibration curves were linear for Mg, Ca, K and Na with coefficient of
determination (R2) ≥ 0.9978 and regression data indicating the excellent linearity for the selected concentration
range for each content. The recovery results were obtained between the ranges 96.9-102.5 %
which were good enough to justify the suitability of the proposed method for its intended applications.
Statistical analysis indicated that there was no significant difference was observed between the proposed
and compendial method at 95 % confidence of interval.
Conclusion: The advantage of the proposed method over the compendial method by virtue of its economy
and fast with reliable results because more reagents and chemicals are consumed in the compendial