Tue, 21 Nov 2017

Method Development and Validation of Clobazam In Bulk and Pharmaceutical Dosage Forms by Using RP-HPLC Method

Senthilkumar GP1*,Parag. S. Mahadik1, S. Parthiban1,T. Tamizhmani1

1.Department of Pharmaceutical Chemistry, Bharathi college of Pharmacy, Bharathinagara, Mandya- Dist, Karnataka, 571422, India.


ABSTRACT

Clobazam is an antiepileptic drug. There have been very less number of analytical methods developed for estimation of Clobazam in pure bulk form and in dosage form. In the present research a simple, accurate, precise and cost effective High performance liquid chromatographic method for the estimation of Clobazam, in bulk and pharmaceutical dosage form was carried out. HPLC method was developed on a Symmetry C-8 (4.6×150mm), 3.5µm particle, reversed-phase column. The mobile phase was acetonitrile: phosphate buffer (0.05M, pH- 4.5), 60:40 (v/v) at a flow rate of 0.8ml/min. The eluate was monitored at 231 nm. The method was validated reaching satisfactory results for selectivity, precision and accuracy. The retention time of the drug was found to be 3.38min in the mobile phase, acetonitrile: 0.05M potassium dihydrogen orthophosphate buffer (pH-4.5) 40: 60 (v/v). A linear response was observed in the range of 20-60µg/ml 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.

Keywords: Clobazam, Anti-epileptic, High performance liquid chromatography, ICH.

 


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