Authors:

Abstract

Background

Lithium is a first line drug used to treat bipolar affective disorder requiring frequent monitoring due to  its narrow therapeutic index. Flame photometry is a reliable quick and cost-effective method of serum lithium estimation.

Objective

We aimed to validate a flame photometry method for serum lithium estimation to compare the results with a different model flame photometer and an ion-selective electrode.

Method

Sherwood 410 flame photometer was used for the analysis. Serum samples were diluted 1:2 using a lithium blank solution containing sodium and potassium. Aqueous lithium standards were prepared using the same blank. The method was validated for the concentration range 0.2-1.5mmol/l. Linearity, recovery, accuracy, precision and stability were determined by standard lithium serum samples representing the lower limit of quantification (LLOQ) 0.2mmol/l, median level of quantification (MLOQ) 0.8mmol/l and the upper limit of quantification (ULOQ) 1.5mmol/l. Five replicates of serum and aqueous lithium samples were used to determine linearity in the range between LLOQ and ULOQ using the coefficient of determination (R2). Five standard serum replicates were used for recovery, accuracy and precision studies. Precision was determined by the coefficient of variation (CV%) on three different days. Results of the flame photometric method were compared with those of a different flame photometric method and an ion-selective electrode method.

Results: The R2 for the aqueous samples and the serum samples was >0.995 demonstrating linearity. The matrix effect ranged between 92.5% and 105% for the LLOQ, MLOQ and ULOQ. The accuracy and precision for LLOQ, MLOQ of and ULOQ were below 15%. Similar results were obtained for the QC samples with the different model flame photometer and ion-selective electrode method.

Conclusion

Keywords: Lithium carbonate, Flame photometry, Therapeutic drug monitoring, Validation