Abstract
A selective ultraperformance liquid chromatographic (UPLC) method for the quantification of valproic acid and its known related impurities using ion pair reagent has been developed. The method includes reversed-phase Acquity HSS T3 column with 100 mm × 2.1 mm i.d. and 1.7 μparticle size. The mobile phase consists of acetonitrile, 5 mM 1-hexanesulphonic acid sodium salt, flow rate is 0.6 mL/min, and UV detection is performed at 215 nm. A system suitability test (SST) was developed to govern the quality of the separation. The developed method has been validated further with respect to linearity, accuracy, precision, selectivity, LOD, LOQ, and Robustness.
Highlights
Valproic acid is chemically known as 2-propylpentanoic acid
There is no paper describing an ultraperformance liquid chromatographic (UPLC) method that allows the separation of valproic acid and its related known impurities in bulk drugs
The selectivity of the valproic acid and its related impurities can be altered by changing the pH of the buffer
Summary
There is no paper describing an ultraperformance liquid chromatographic (UPLC) method that allows the separation of valproic acid and its related known impurities in bulk drugs. Some articles are available on isocratic HPLC methods for the determination of valproic acid [6–10]. The capillary electrophoresis methods for the determination of valproic acid in different biological samples are available [27–30]. The objective of this study is to develop a more selective LC method for the analysis of valproic acid and its related impurities. It is accurate, precise, selective, robust, and linear with a reasonable analysis time. The developed method is applicable for the analysis of drug substances as well as commercially available drug products containing valproic acid. This work deals with the validation of methods for the quantification of valproic acid and its impurities
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