Development and Validation of a Dissolution Test Method for Albendazole and Praziquantel in Their Combined Dosage Form

Silvana E Vignaduzzo,María A Operto,Patricia M Castellano

doi:10.5935/0103-5053.20150033

Abstract

A dissolution test method and an analytical procedure by HPLC were developed and validated for the evaluation of the dissolution of tablets containing albendazole and praziquantel. Two different commercially tablets containing 500 mg of albendazole and 50 mg of praziquantel for veterinary use were selected for this study. A dissolution medium containing a mixture of 300 mL ethanol and 600 mL of 0.1 mol L-1 HCl was found suitable to ensure sink conditions. USP Apparatus 2, 900 mL dissolution medium and 75 rpm were fixed. Dissolution profiles were generated at 45 min. Dissolution samples were analyzed with a reversed-phase high-performance liquid chromatography (RP-HPLC) method with ultraviolet (UV) detection at 210 nm, developed and validated for this purpose. Each product was also assayed for analyte content according to USP 35. The dissolution test described here could be proposed as a means of assessing finished product quality.

Highlights

IntroductionPraziquantel (PRA) [2-(cyclohexylcarbonyl)1,2,3,6,7,11b-hexahydro-4hpyrazino(2,1a) isoquinoline4-one] (Figure 1) is a pyrazinoisoquinolone derivative which has been shown to be highly effective against a broad spectrum of cestode and trematoda parasites in humans and animals.[2] The detailed molecular mechanism of action of PRA has not been elucidated yet, but it rapidly causes tegumental damage and paralytic muscular contraction of parasites
The high-performance liquid chromatography (HPLC) method was optimized by a smart approach using experimental design methodology
The HPLC method was used to quantify both analytes for the quality control of tablets of three brands of veterinary tablets

Summary

Introduction

Praziquantel (PRA) [2-(cyclohexylcarbonyl)1,2,3,6,7,11b-hexahydro-4hpyrazino(2,1a) isoquinoline4-one] (Figure 1) is a pyrazinoisoquinolone derivative which has been shown to be highly effective against a broad spectrum of cestode and trematoda parasites in humans and animals.[2] The detailed molecular mechanism of action of PRA has not been elucidated yet, but it rapidly causes tegumental damage and paralytic muscular contraction of parasites. This may be due to an action on parasite glutathione S-transferase and intracellular calcium level.[3]

Methods

Results

Conclusion