Desenvolvimento de métodos para análise do besilato de anlodipino para inclusão da monografia na farmacopéia brasileira [thesis]

Helen Dutra Leite
The objective of this research was to develop and validate analytical methods for the amlodipine besylate (ABC) determination in tablets. Simple, accurate and precise spectrophotometric and HPLC methods were validate for ABC determination in samples containing 5.0 and 10.0 mg of ABC / tablet. For the spectrophotometric method, the first dilutions of samples were made in methanol and the consecutive in distilled water. Determination was made at 364.4 nm. Linearity was in the range of 41.0-61.0
more » ... g/mL and r= 0.9996. The detection and quantitation limits were respectively, 0.54 IJg/mL and 1.80 IJg/mL. Accuracy and precision were respectively, 98.99% and 0.37%. For HPLC analysis, the following conditions were used: a LiChrospher ®1 00 RP-18 Merck® (250 mm x 4,6 mm, 5!-!m) column; methanol: water with 1 % of triethylamine adjusted to pH 5.0 with phosphoric acid (35:65), as mobile phase; a flow rate of 1.0 mL /min; UV detection at 238 nm and temperature of 22 ±1 °C . Retention time was 3.7 min o Linearity was in the range of 50.0 -350.0 IJg/mL and r = 0.9999. The detection and quantitation limits were respectively, 2.26 IJg/mL and 7.52 IJg/mL. Accuracy and precision were respectively, 100.18% and 0.37%. Both methods can be used in routine analysis for quality control of tablets containing ABC.
doi:10.11606/d.9.2017.tde-26012017-160944 fatcat:vvgztrq6afbmtgqkfb2bcdqanq