Abstract
In the present research a simple, accurate, precise and cost-effective High-performance thin layer chromatographic method for the estimation of clobazam, in bulk and pharmaceutical dosage form was illustrated. The RF value of the drug was found to be 0.74 in the mobile phase, acetone: toluene: formic acid (1: 1: 0.05 v/v/v). A linear response was observed in the range of 100-700 ng with a regression coefficient of 0.999. Validation parameters were carried out as per the guidelines of International Conference for Harmonization (ICH). This method can be used in the industries for determination of clobazam to analyze the quality of formulation without interference of the excipients.Â
Highlights
Clobazam is an antiepileptic drug belonging to the benzodiazepine series coming under the class of Anticonvulsant drugs and chemically called as 7-chloro-1,5-dihydro-1-methyl-5-phenyl-1,5-benzodiazepine2,4(3H)-dione (Fig 1)
Clobazam bulk powder is a white crystal with molecular weight of 300.7. the drug is slightly soluble in water and soluble in organic solvents [3]
Today majority of marketed antiepileptic dosage forms are of clobazam e.g. Frisium, Urbanyl, etc., There are several research papers which illustrates the method for estimation of clobazam by colorimetry and HPLC in bulk and pharmaceutical dosage form [6,7]
Summary
Clobazam is an antiepileptic drug belonging to the benzodiazepine series coming under the class of Anticonvulsant drugs and chemically called as 7-chloro-1,5-dihydro-1-methyl-5-phenyl-1,5-benzodiazepine2,4(3H)-dione (Fig 1). Clobazam is a long-acting 1,5-benzodiazepine with uses similar to those of diazepam as 1,4-benzodiazepine. It is used in the treatment of epilepsy in association with other antiepileptics. Today majority of marketed antiepileptic dosage forms are of clobazam e.g. Frisium, Urbanyl, etc., There are several research papers which illustrates the method for estimation of clobazam by colorimetry and HPLC in bulk and pharmaceutical dosage form [6,7]. There have been very a smaller number of analytical methods developed for estimation of clobazam in pure bulk form and in dosage form. In the present study method development and validation was carried out by HPTLC method [9]
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