Determination of Magnesium Valproate and Its Process Related Impurities by Ultraperformance Liquid Chromatography

Table 2

Summary of validation study.

Validation experiment	PA	2-EPA	2-1-MEPA	VA	MgVA
Specificity	No interference	No interference	No interference	No interference	No interference
LOQ (𝜇g/mL)	2.0	2.0	2.0	2.0	2.0
LOD (𝜇g/mL)	1.0	1.0	1.0	1.0	1.0
Linearity
(I) Correlation coefficient	0.999	0.998	0.999	0.997	0.998
(II) Regression equation	𝑦=10.15𝑥−4.714	𝑦=10.06𝑥+21	𝑦=10.12𝑥+5.285	𝑦=10.37𝑥−21.85	𝑦=10.29𝑥−13.28
Method precision (𝑛=6)	%RSD = 0.2	%RSD = 0.2	%RSD = 0.2	%RSD = 1.2	%RSD = 0.1
Int. precision (𝑛=6)	%RSD = 1.2	%RSD = 0.8	%RSD = 0.8	%RSD = 1.8	%RSD = 0.7
Accuracy (% recovery)	99–101	98–100	99-100	98–102	99-100
Robustness	No significant change	No significant change	No significant change	No significant change	No significant change