Article Details

Dissolution Method Development and Validation of Tramadol Hydrochloride Capsules

Farheen H., Mamatha T., Yasmeen Z. and Venkateswara Rao J.


ABSTRACT

A dissolution method was developed and validated for evaluation of the dissolution behavior of capsuledosage form of tramadol hydrochloride as there was no official method available. The UV spectrophotometricmethod developed was based on the direct estimation method using 271 nm as ?max of tramadolhydrochloride. The method was validated according to International Conference on Harmonisation (ICH)guidelines which include accuracy, precision, specificity, linearity, and analytical range. In addition, solubilityand stability of the drug in dissolution medium i.e., 0.1 N HCl was studied. The established dissolutionconditions were 900 mL dissolution medium at temperature 37 0.5C, using USP apparatus I at stirringrate of 100 rpm for 30 min. The corresponding dissolution profiles were constructed and all the selectedbrands showed more than 80% drug release with in 30 min. Thus, the proposed dissolution method can beapplied successfully for the quality control of tramadol hydrochloride capsules.
Year 2013 | Volume No. 50 | Issue No.8 | Page No. 47
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