APPROACH OF THE STATE PHARMACOPEIA OF UKRAINE TO ANALYTICAL PROCEDURES VALIDATION ON THE EXAMPLE OF CHLORIDE IONS ASSAY IN PERITONEAL DIALYSIS SOLUTIONS
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The objective of this study was to develop and validate an alternative analytical procedure for the total chloride assay in solutions for peritoneal dialysis (PD). The proposed analytical procedure was validated according to the requirements of the International Conference on Harmonization guideline: Topic ICH Q2(R1) and the approach of the State Pharmacopeia of Ukraine (SPU). The analytical procedure was specific. The linearity of the procedure was evaluated in the concentration range of 76 to 114 mmol/L of chloride ions (80-120 % of the stated content 95 mmol/L) with the regression equation y=1.0029•X-0.2263 and a correlation coefficient of 0.9989. The y-intercept of the regression line did not exceed the maximum permissible value of 2.6. The residual standard deviation (s0=0.65) of the calibration curve met the requirement for max s0 (0.84). The mean recovery was found as 100.07%±0.62 %. The precision study also showed a low value of one-sided 95% confidence limit (∆Z=1.15%) that did not exceed the critical value of 1.6%. The accuracy study also showed that the systematic error had not differed statistically from zero. The developed analytical procedure was also found to be robust and reproducible as contents differences were less 1.6%. The reproducibility studies were conducted with different samples of the same laboratory-made PD solutions in different days and laboratories. The performed studies indicated that the developed analytical procedure is simple, fast and cost-efficient, specific, linear, precise, accurate, and robust. The presented approach could be also applied to the validation of other assay analytical procedures.
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