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Development and validation of alternative methods by non-aqueous acid-base titration and derivative ultraviolet spectrophotometry for quantification of sildenafil in raw material and tablets
Silva, Taízia Dutra; Toledo, Cibele Rodrigues; Vianna-Soares, Cristina Duarte.
  • Silva, Taízia Dutra; Federal University of Minas Gerais. Faculty of Pharmacy. Department of Pharmaceutical Products. Belo Horizonte. BR
  • Toledo, Cibele Rodrigues; Federal University of Minas Gerais. Faculty of Pharmacy. Department of Pharmaceutical Products. Belo Horizonte. BR
  • Vianna-Soares, Cristina Duarte; Federal University of Minas Gerais. Faculty of Pharmacy. Department of Pharmaceutical Products. Belo Horizonte. BR
Braz. J. Pharm. Sci. (Online) ; 53(1): e15181, 2017. tab, graf
Article in English | LILACS | ID: biblio-839459
ABSTRACT
Sildenafil citrate (SILC) is a potent phosphodiesterase-5 inhibitor used for erectile dysfunction and pulmonary hypertension. This study shows two simple, fast and alternative analytical methods for SILC determination by non-aqueous titration and by derivative ultraviolet spectrophotometry (DUS) in active pharmaceutical ingredient and/or dosage forms. The quantitation method of SILC active pharmaceutical ingredient by non-aqueous acid-base titration was developed using methanol as solvent and 0.1 mol/L of perchloric acid in acetic acid as titrant. The endpoint was potentiometrically detected. The non-aqueous titration method shows satisfactory repeatability and intermediate precision (RSD 0.70-1.09%). The neutralization reaction occurred in the stoichiometric ratio 11 in methanol. The determination of SILC active pharmaceutical ingredient or dosage forms by DUS was developed in the linear range from 10 to 40 µg/mL, in 0.01 mol/L HCl, using the first order zero-peak method at λ 256 nm. The DUS method shows selectivity toward tablets excipients, appropriate linearity (R2 0.9996), trueness (recovery range 98.86-99.30%), repeatability and intermediate precision in three concentration levels (RSD 1.17-1.28%; 1.29-1.71%, respectively). Therefore, the methods developed are excellent alternatives to sophisticated instrumental methods and can be easily applied in any pharmaceutical laboratory routine due to simple and fast executions.
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Full text: Available Index: LILACS (Americas) Main subject: Spectrophotometry, Ultraviolet / Titrimetry / Sildenafil Citrate Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2017 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Minas Gerais/BR

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Full text: Available Index: LILACS (Americas) Main subject: Spectrophotometry, Ultraviolet / Titrimetry / Sildenafil Citrate Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2017 Type: Article Affiliation country: Brazil Institution/Affiliation country: Federal University of Minas Gerais/BR