Title: Determination and Bioequivalence of Andrographolide by HPLC-MS
Abstract: Objective:To develop an HPLC-MS method to determine andrographolide in plasma and evaluate the bioavailability of andrographolide dispersible tablets. Methods:Sample preparation was based on liquid-liquid extraction. The compounds were separated on a Hanbon C18 column (4.6 mm×150 mm,5 μm) with mobile phase of methanol-water (72∶28,v/v) and analyzed by MS detector. Nevirapine was the internal standard and the target ions were m/z 373.6 for andrographolide and m/z 267.7 for the internal standard. In a randomized crossover design,20 healthy male volunteers were given 0.15 g andrographolide dispersible tablets T (test drug) or R (reference drug). The plasma samples were obtained and determined by the newly-developed HPLC-MS method and the pharmacokinetics and bioavailability were studied. Results:The calibration curve of andrographolide were liner within the range of 1.343~268.6 μg· L-1 with the limit of quantity 1.343 μg·L-1,the methodology recoveries were in the range of 95.7%~104.7%. Inter-day and intra-day RSDs were less than 6.4% and 12.4%,respectively. Pharmacokinetic parameters of andrographolide after a single dose of T and R were as following:Cmax were (114.26±37.20) μg·L-1 and (107.95±32.44) μg·L-1; Tmax were (1.0±0.3) h and (1.1±0.3) h; AUC0 36 were (375.96±89.86) μg·h·L-1 and (368.84±89.14) μg·h·L-1; AUC0∞ were (388.39±91.14) μg·h·L-1 and (382.81±97.14) μg ·h· L-1; t1/2 were (7.65±2.24) h and (7.90±2.16) h. Conclusions:The method is selective,sensitive and rapid for andrographolide determination. The results of ANOVA analysis and two one-side t tests show that there is no significant difference between the pharmacokinetic parameters of the two formulations and bioequivalence is observed.
Publication Year: 2009
Publication Date: 2009-01-01
Language: en
Type: article
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