Page 90 - GTM-2-3

Global Translational Medicine HPLC-UV lacosamide quantification

Figure 5. Comparisons of specificity in forced degradation studies.

the CI 95% included the value zero, indicating that the 3.2.6. Stability
intercept was not statistically different from zero.
The stability study revealed that unprocessed plasma
3.2.3. Precision samples containing lacosamide are not stable at room
temperature and should be stored under cold conditions.
In the evaluation of precision, the methodology The maximum storage times are summarized in Table 2.
performed adequately, with CV% values of 6.76% and
12.64% in the repeatability test and the intermediate When processed using this analytical technique, the
precision test, respectively. Both values were lower than samples remain stable for 1 week under all storage
the 15.00% limit. conditions. Significant changes in areas are observed in
samples subjected to freeze-thaw cycles, but this effect is
3.2.4. Accuracy primarily seen when exposed to −20°C.
This analysis revealed that the average recovery percentage 3.3. Therapeutic drug monitoring of lacosamide in
was 100.2%, along with an experimental t-value lower than epileptic patients
the tabulated one. In all cases, the CV% remained below
15%, and the variances of the tested concentrations were The quantification of lacosamide was satisfactorily carried
equivalent, as evidenced by the experimental Cochran’s out in five adult patients. A total of 10 blood samples were
G value being lower than the tabulated one. Therefore, obtained at steady-state, and lacosamide concentrations
concentration does not significantly influence the were measured using the previously developed and
variability of the results. validated HPLC method (Table 3). The lacosamide dose
ranged from 200 – 500 mg/day, and the measured plasma
3.2.5. Sensitivity levels (troughs and peaks) ranged between 3.6 and

We achieved 0.69 µg/ml for LOD and 2.29 µg/ml for LOQ. 13.8 ug/ml.

Volume 2 Issue 3 (2023) 8 https://doi.org/10.36922/gtm.1265