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 60 F254 TLC 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 with r2=.9995 in 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.
Highlights
Carbamazepine (CBZ), 5-H-Dibenz [b.f] azepine-5-carboxomide, is widely prescribed as an anticonvulsant, antiepileptic, and antimanic drug
Various methods have been reported for the determination of CBZ in pharmaceutical preparations including spectrophotometric methods [4,5,6,7,8], spectrofluorimetry method [9], gas-liquid chromatography (GC) [10, 11], FTRaman spectroscopy [12], planar chromatography [13], and high performance liquid chromatography (HPLC) [14,15,16,17,18,19,20,21,22,23,24]
The present paper describes the development and validation of HPTLC method for routine estimation of CBZ from bulk and pharmaceutical dosage forms such as tablets and mucoadhesive microemulsion (MME) formulations and solution developed in-house and for in vitro release study
Summary
Carbamazepine (CBZ), 5-H-Dibenz [b.f] azepine-5-carboxomide, is widely prescribed as an anticonvulsant, antiepileptic, and antimanic drug. HPLC-based separation methods may not be suitable for the determination of drug from lipidbased delivery systems such as mucoadhesive microemulsion (MME) formulations. Major advantage of HPTLC is its ability to analyze several samples simultaneously using a small quantity of mobile phase This reduces time and cost of analysis. In case of HPTLC, there are no restrictions on the choice of solvents and mobile phases; drug and lipophilic excipients can be dissolved in a suitable solvent that would evaporate during spotting on TLC plate, leaving behind analyte as a thin band For such methods, extraction procedure is not required always and could be developed for analyzing drug without any interference from excipients [25,26,27,28,29]. The present paper describes the development and validation of HPTLC method for routine estimation of CBZ from bulk and pharmaceutical dosage forms such as tablets and MME formulations and solution developed in-house and for in vitro release study
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