THẨM ĐỊNH QUY TRÌNH ĐỊNH LƯỢNG THUỐC CHỐNG TĂNG HUYẾT ÁP AMLODIPINE BESYLATE DẠNG VIÊN NANG BẰNG PHƯƠNG PHÁP HPLC ĐẦU DÒ DAD

Tóm tắt

The aim of this study was to validate a protocol for the determination of amlodipine besylate in capsules
using the HPLC method with a DAD detector at a wavelength of 237 nm. The HPLC separation was carried
out using a C18 column (25 cm × 4,6 mm; 5 μm) and the mobile phase system was used as CH3OH and
solution pH 3,0 (60:40) belonging to isocratic elution mode. The results of the validation proved that the
method showed good selectivity, linearity with R2
of 0,9997, a low limit of detection (LOD) of 1,27 ppm, a
limit of quantification (LOQ) of 3,8 ppm, an accuracy of 100,02%, and a precision of the method (RSD) of
less than 2%. In particular, the verified method was also applied to determine the amount of amlodipine
besylate in three real samples on the market, and the results indicated that the content of amlodipine
besylate in all three preparations was above 94% and qualified as prescribed by the Vietnam
Pharmacopoeia V.