Development and Validation of a HPTLC Method to Determine Serum Zonisamide levels for Therapeutic Drug Monitoring in Clinical Settings

Abstract

Munshi and Gawde: Development and Validation of a HPTLC method to Determine Serum Zonisamide Levels This investigation is aimed to develop and validate a high-performance thin layer chromatography method for quantitative determination of serum zonisamide levels. Chromatographic separation was carried out on a silica gel 60F254 plate using a mixture of ethyl acetate:methanol:toluene (4:1:5) as the mobile phase. Densitometric detection was carried out at 254 nm. The method was validated for linearity, precision, selectivity, limit of detection, limit of quantification and accuracy. Linear calibration curves in the range of 5 to 80 µg/band gave a correlation coefficient of 0.991. The intra-day (n=6) and inter-day (n=18) precision, expressed as the relative standard deviation were in the range of 2.83 to 3.27 % and from 2.09 to 4.39 %. The limits of detection and quantification were found to be 1.07 and 3.15 µg/band, respectively. Accuracy was calculated as percent recovery and was found to be 97.52 and 115.23 %. Theophylline was used as an internal standard, which gave a well separated peak at R f 0.36 without interfering with zonisamide. The method was found to be specific with no matrix interference. Thus, the method developed for the estimation of serum zonisamide level is simple, cost-effective and reliable for therapeutic drug monitoring.

Ion-Channel Antiepileptic Drugs: An Analytical Perspective on the Therapeutic Drug Monitoring (TDM) of Ezogabine, Lacosamide, and Zonisamide

“…A peculiar technique for TDM, namely high-performance thin-layer chromatography (HPTLC), has been also used for ZNS analysis in human plasma [108]. Silica gel-coated [106], (c) [107], and (d) [108].…”

“…A peculiar technique for TDM, namely high-performance thin-layer chromatography (HPTLC), has been also used for ZNS analysis in human plasma [108]. Silica gel-coated aluminium plates were used, and the mobile phase was an ethyl acetate/methanol/toluene mixture; densitometric detection was carried out at 254 nm.…”

“…Figure 7. Chemical structures of the internal standards (ISs) used in references (a) [105], (b)[106], (c)[107], and (d)[108].…”

Green analytical chemistry and experimental design: a combined approach for the analysis of zonisamide

“…By reviewing the literature, different methods were reported for determining ZNS either in pharmaceutical dosage form or biological fluids utilizing HPLC [ 13 – 18 ], capillary electrophoresis [ 19 , 20 ], HPTLC [ 21 , 22 ], and electroreduction at hanging mercury drop electrode [ 23 ]. To date, only a few stability-indicating methods were published for ZNS determination in the presence of its degradation products using HPLC [ 24 – 28 ] and spectrophotometric techniques [ 26 , 29 ].…”