Study on Determination Method for Dissolution of Pentoxyverine Citrate and Guaifenesin Tablets / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the dissolution determination of Pentoxyverine citrate and guaifenesin tab-lets,and to compare the difference of preparations from different manufactures. METHODS:The paddle method was used to deter-mine the dissolution,using water as medium with medium volume of 1000 mL and rotation speed of 75 r/min,sampling at 45 min. HPLC method was used to determine the accumulative dissolution of pentoxyverine citrate and guaifenesinCAPCELL PAK C18 MGⅡ S-5 column;mobile phase of acetonitrile-triethylamine phosphoric buffer solution(pH 2.6±0.05)(3367,V/V),flow rate of 1.0 mL/min,detection wavelength of 215 nm(pentoxyverine citrate)and 275 nm(guaifenesin),column temperature of 35 ℃,sample size of 20 μL. RESULTS:The linear range of pentoxyverine citrate and guaifenesin were 5.0916-50.9155 μg/mL(r=0.9999)and 29.9995-299.9952 μg/mL(r=0.9999),respectively. RSDs of precision,stability and reproducibility tests were all lower than 2.0%. Average recoveries were 97.90%-100.68%(RSD=0.95%,n=9)and 97.09%-101.85%(RSD=1.32%,n=9). Average accu-mulative dissolution of pentoxyverine citrate in 6 manufactures of samples were 12%,98%,66%,97%,91%,32%(n=3);those of guaifenesin were 8%,95%,68%,90%,93%,18%(n=3),respectively. CONCLUSIONS:The method is simple,ac-curate,sensitive,specific and suitable for the dissolution determination of Pentoxyverine citrate and guaifenesin tablets. The dissolu-tion of samples between different manufactures and the same manufactures different batches are quite different.