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Development of dissolution test method for a telmisartan/amlodipine besylate combination using synchronous derivative spectrofluorimetry BJPS
Anumolu,Panikumar Durga; Neeli,Sirisha; Anuganti,Haripriya; Ranganatham,Sathesh Babu Puvvadi; Satya,Subrahmanyam Chavali Venkata.
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...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Combined dosage forms/quality control; Dissolution test/combined dosage forms; Telmisartan; Amlodipine besylate; Spectrofluorimetry/quantification analysis.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200329
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