A Validated Non-compendial Method for Determination of Haemodialysis Concentrate’s Contents and its Comparison with Compendial Method: Application of ISO 13958:2014 Standard

Abstract

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) comprise of sodium bicarbonate alone or in combination with sodium chloride. Aim: Present research aimed to develop and validate a rapid method for determination of cations and anions in haemodialysis concentrates in solution and powder form by choosing one of technique among various suggested in ISO 13958:2014. Method: 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 justified the suitability of proposed method for its intended applications. Statistical analysis indicated that there was no significant difference was observed between proposed and compendial method at 95 % confidence of interval. Conclusion: The advantage of proposed method over the compendial method by virtue of its economy and fast with reliable results because more reagents and chemicals are consumed in compendial method.