Development and Validation of HPTLC Method for Estimation of Carbamazepine in Formulations and Its In Vitro Release Study

Abstract

A new, simple, and rapid high-performance thin-layer chromatographic method was developed and validated for quantitative determination of Carbamazepine. Carbamazepine was chromatographed on silica gel 60F254TLC plate using ethyl acetate-toluene-methanol (5.0 + 4.0 + 1.0 v/v/v) as mobile phase. Carbamazepine was quantified by densitometric analysis at 285 nm. The method was found to give compact spots for the drug (Rf=0.47 ± 0.01). The linear regression analysis data for the calibration plots showed good linear relationship withr2=.9995in the concentration range 100–600 ng/spot. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization guidelines. The minimum detectable amount was found to be 16.7 ng/spot, whereas the limit of quantitation was found to be 50.44 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of Carbamazepine. The method was successfully employed for the estimation of equilibrium solubility, quantification of Carbamazepine as a bulk drug, in commercially available preparation, and in-house developed mucoadhesive microemulsion formulations and solution.

Development and validation of an HPLC–UV method for the quantification of carbamazepine in rabbit plasma

“…Simultaneous determinations of CBZ and its metabolites in biological fluids and drug products (Burke and Thenot, 1985;Owen et al, 2001) have been published, including, solid-liquid extraction (Wad, 1984), liquid-liquid extraction (Rouan et al, 1992), column-switching (Juergens, 1984), deproteinization (Liu et al, 1993), spectrofluorimetry method (Huang et al, 2002), gas-liquid chromatography (Chen and Bashi, 1991), FT-Raman spectroscopy (Auer et al, 2003), planar chromatography (Mennickent et al, 2009), stir bar-sorptive extraction and high-performance liquid chromatography-UV detection (SBSE/HPLC-UV) (Queiroz et al, 2008) and high-performance thin layer chromatography (HPTLC) (Patel et al, 2011). Also, LC-mass spectrometry methods (Breton et al, 2005;Van Rooyen et al, 2002;Miao and Metcalfe, 2003;Zhu et al, 2005) have been reported for the detection of CBZ and its metabolites in aquatic environments and in plasma.…”

Microemulsion-based drug delivery system for transnasal delivery of Carbamazepine: preliminary brain-targeting study

“…CMP content in the formulations was assayed using a high-performance thin layer chromatography (Patel et al, 2010). The average droplet size and polydispersity index (PDI) of ME was determined using photon correlation spectroscopy (PCS) with in-built Zetasizer (Nano ZS, Malvern Instruments, UK) at 633 nm.…”

UFLC Method Development for the Quantification of Carbamazepine in Blood Samples and an Application to Pharmacokinetic Study

“…In addition, depending on the weak tissue protein binding of drug, methanol was used for protein precipitation (1:1) in order to obtain satisfactory values for recovery of CBZ. The selected chromatographic conditions provided optimum resolution of CBZ comparision to previous methods (28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39). Using the chromatographic conditions described above, the selectivity was further evidenced by the ability of the assay to separate the drug and the internal standard from plasma samples without interference from any endogenous material with a good separation and resolution of their peaks.…”