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Journal of Applied Chemistry
Volume 2013 (2013), Article ID 352984, 7 pages
http://dx.doi.org/10.1155/2013/352984
Research Article

Development of Stability Indicating LC Method for the Estimation of Tolperisone in Bulk and Pharmaceutical Dosage Form

1Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, Beyond GIDC Phase IV, Vithal Udyognagar, New Vallabh Vidyanagar, Anand, Gujarat 388121, India
2Department of Pharmacology, Indukaka Ipcowala College of Pharmacy, Beyond GIDC Phase IV, Vithal Udyognagar, New Vallabh Vidyanagar, Anand, Gujarat 388121, India

Received 13 August 2013; Accepted 28 October 2013

Academic Editor: Rassoul Dinarvand

Copyright © 2013 U. K. Chhalotiya et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A rapid, specific, and sensitive reverse phase high performance liquid chromatographic method has been developed and validated for analysis of tolperisone in both bulk and pharmaceutical dosage form. The HPLC method was performed with a reversed phase C18 SunFire column (250 mm × 4.6 mm i.d., 5 mm particle size), detection at 261 nm and a mixture of methanol, water and pH 7.5 adjusted by use of 1% solution of triethylamine (60 : 40) as mobile phase. The flow rate was 1.0 mL min−1 and effluents were monitored at 261 nm. The retention time of tolperisone was 4.8 min. Tolperisone was subjected to acid and alkali hydrolysis, chemical oxidation, wet hydrolysis, dry heat degradation, and sunlight degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision, and robustness. The method was successfully applied to the estimation of tolperisone in tablet dosage forms.