Determination of oxcarbazepine and its related substances using UHPLC method with UV detection

Abstract

A simple and rapid ultra-high performance liquid chromatographic (UHPLC) method for the separation and determination of oxcarbazepine and its related substances in tablets, was developed. Chromatographic separation of oxcarbazepine from its related substances (degradation and by-products) was achieved on a reversed phase C 18 column (Pinnacle DB C18, RESTEK, 100 x 2.1 mm, 1.9 µm particle size) using gradient program with water (as mobile phase A) and acetonitrile (as mobile phase B), at a flow rate 0.5 mL min-1 and UV detection at 254 nm. The column temperature was 30°C.The method has good selectivity towards oxcarbazepine and its related substances. The accuracy of the method for oxcarbazepine assay, expressed as mean recovery was 101.8 %, and of the method for quantification of degradation products was 95.9 %-103.3 %. Limit of quantification for oxcarbazepine and its degradation products ranged from 0.60 µg mL-1 to 1.30 µg mL-1. The linearity range for oxcarbazepine assay was from 2.4 to 3.60 mg mL-1 (R 2 =0.999). Mean value for oxcarbazepine assay from the tablets was 299.92 mg (label claim 300 mg). The method can be used for routine analysis and the quality control of oxcarbazepine drug substance and its formulated products.

The use of an RP-HPLC-UV method for the analysis of oxcarbazepine in the presence of its preservatives; stability studies and application to human plasma samples

“…A simple method to monitor plasma concentrations of oxcarbazepine, carbamazepine, their main metabolites and lamotrigine in epileptic patients [9]. Oxcarbazepine was also determined using UHPLC technique [10].…”

Appraisal of the greenness profile of a chromatographic method for the simultaneous estimation of carbamazepine and oxcarbazepine, along with two potential impurities and three formulation excipients

“…2 OX is a non-official drug that has been found to have different impurities such as CBZ and IST. 5 Moreover, CBZ and OX are individually formulated in tablet and suspension dosage forms, marketed as Tegretol® and Trileptal®, respectively. The marketed oral suspensions of CBZ and OX, as labeled by the manufacturer, contain methyl paraben (MP), propyl paraben (PP) and sorbic acid (SA) as preservatives.…”

“… 13,14 OX was estimated in tablets by TLC-densitometric 15 and different HPLC 16,17 methods. It was also determined in the presence of its degradation products or related substances by TLC-densitometric, 18 HPLC 5,19–21 and LC-MS/MS 22 methods. Additionally, it was analyzed along with its metabolites by HPLC 23,24 and LC-MS/MS 25–27 methods.…”