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Development and validation of an UV-spectrophotometric method for the dissolution studies of sitagliptin tablets

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962 ISSN 0326-2383

KEY WORDS: Dissolution, Sitagliptin, UV-spectrophotometry, Validation. * Author to whom correspondence should be addressed. E-mail: crolim@smail.ufsm.br

Latin American Journal of Pharmacy

(formerly

Acta Farmacéutica Bonaerense)

Lat. Am. J. Pharm.

29

(6): 962-7 (2010)

Original Article

Received: December 15, 2009 Accepted: January 30, 2010

Development and Validation of an UV-spectrophotometric Method

for the Dissolution Studies of Sitagliptin Tablets

Aline RAVANELLO

1

, Gabriele DADALT

2

, Bruna G.S. TORRES

2

, Felipe K. HURTADO

1

,

Ana I.P. MARCOLINO

2

& Clarice M.B. ROLIM

1

*

1

Programa de Pós-Graduação em Ciências Farmacêuticas, Departamento de Farmácia Industrial,

Centro de Ciências da Saúde, Universidade Federal de Santa Maria (UFSM),

Av. Roraima 1000, 97105-900, Santa Maria, RS, Brazil

2

Curso de Farmácia, Centro de Ciências da Saúde, Universidade Federal de Santa Maria (UFSM),

Av. Roraima 1000, 97105-900, Santa Maria, RS, Brazil

SUMMARY. A simple UV-spectrophotometric method was developed and validated for the analysis and dissolution studies of sitagliptin phosphate in tablets. Specificity test indicated an adequate UV detection at 267 nm. The method was validated regarding Specificity/accuracy/precision (RSD < 2 %), linearity (r2=

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