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Global Translational Medicine HPLC-UV lacosamide quantification

liquid extraction solvents, including dichloromethane, 3.2.1. Specificity
cyclohexane, hexane, chloroform, methyl tert-butyl ether, When analyzing various types of plasma, including normal,
and ethyl acetate, were evaluated. Ethyl acetate was selected hemolyzed, icteric, and hyperlipidemic plasma (Figure 3),
due to its ability to provide stable and acceptable recovery a comparison was made between the non-specific peaks
percentages for both molecules. observed and the area of the lowest level of the curve of

Table 1 presents the results of the system suitability lacosamide and the internal standard area. In all cases, the
test for the pre-selected parameters, demonstrating that non-specific peaks accounted for less than 10% of the total
all values fall within acceptable limits. The characteristic area. Furthermore, the retention times of both analytes did
chromatogram is depicted in Figure 1, while the UV not overlap with those of commonly used drugs, as shown
absorption spectra of lacosamide and propranolol are in Figure 4. In addition, forced degradation studies yielded
illustrated in Figure 2. optimal results (Figure 5).

3.2. Validation 3.2.2. Linearity
All the results of the validation parameter evaluation are The equation of the linear model is as follows:
summarized in Table 2. Area ratio = 2.4069 + 10272.1754 (II)

× lacosamide concentration
Table 1. System suitability
The coefficients R and R were 0.9985 and 0.9970,
2
Parameter Acceptance Results respectively, in accordance with the obtained linear
criteria Lacosamide Propranolol regression curve.
Theoretical plates (n) >2000 a 28845±549 30648±641 The t-test for the slope (t exp: 73.4657) resulted in a
Tailing ≤2.0 a 1.00±0.02 1.12±0.02 value higher than the tabulated t-value for n-2 degrees of
Resolution >2.0 a 18.96±0.16 freedom at a significance level of P = 95% (t [4;0.05: 2.78]).
Capacity factor (K’) 1 – 20 a 0.52 1.37 This indicates that the slope is statistically different from zero.
Retention time <10 min b 3.8 min 5.9 min The total coefficient of variation of the response factors was
Repeatability of <1.0 b 0.05% 0.05% <15%.
retention time (CV%) Conversely, the experimental t-value for the intercept
Notes: By FDA requirement . Establish by work group. (t exp: 1.0242) was lower than the t (4;0.05) value, and
a
[20] b

Figure 1. Characteristic chromatogram of lacosamide and propranolol in plasma.

Volume 2 Issue 3 (2023) 5 https://doi.org/10.36922/gtm.1265