Development of dissolution test method for a telmisartan/amlodipine besylate combination using synchronous derivative spectrofluorimetry

Panikumar Durga Anumolu,Sirisha Neeli,Sathesh Babu Puvvadi Ranganatham,Haripriya Anuganti,Subrahmanyam Chavali Venkata Satya

doi:10.1590/s1984-82502014000200012

Abstract

The dissolution process is considered an important in vitro tool to evaluate product quality and drug release behavior. Single dissolution methods for the analysis of combined dosage forms are preferred to simplify quality control testing. The objective of the present work was to develop and validate a single dissolution test for a telmisartan (TEL) and amlodipine besylate (AML) combined tablet dosage form. The sink conditions, stability and specificity of both drugs in different dissolution media were tested to choose a discriminatory dissolution method, which uses an USP type-II apparatus with a paddle rotating at 75 rpm, with 900 mL of simulated gastric fluid (SGF without enzymes) as the dissolution medium. This dissolution methodology provided good dissolution profiles for both TEL and AML and was able to discriminate changes in the composition and manufacturing process. To quantify both drugs simultaneously, a synchronous first derivative spectrofluorimetric method was developed and validated. Drug release was analyzed by a fluorimetric method at 458 nm and 675 nm for AML and TEL, respectively. The dissolution method was validated as per ICH guidance.

Highlights

Drug dissolution testing an important analytical technique to evaluate product quality, to assess drug release behavior and to discriminate changes in the formulation and manufacturing process (Kulkarni et al, 2012)
The selection of a dissolution test method was based on screening studies using a USP type II apparatus at a paddle speed of 50/75 rpm
The selection of a dissolution medium to provide adequate solubility and stability of both TEL and amlodipine besylate (AML) was critical for the selected dissolution method

Summary

Introduction

Drug dissolution testing an important analytical technique to evaluate product quality, to assess drug release behavior and to discriminate changes in the formulation and manufacturing process (Kulkarni et al, 2012). The development of a dissolution method for a drug product with limited water solubility and combinations of drugs has been a challenge for both the pharmaceutical industry and regulatory agencies (Soni et al, 2008; Dressman et al, 1998; Oliveira et al, 2009). There is increased demand for biorelevant dissolution media, which have the ability to discriminate changes in the formulation and manufacturing process (He et al, 2004; Panikumar et al, 2012; Menegola et al, 2007). A single dissolution method for the analysis of multiple API active components in combinations present in a dosage form is preferred to simplify quality control testing procedures (Vignaduzzo et al, 2010; Huang et al, 2011; Panikumar et al, 2013; Zongyun et al, 2011)

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