The Consideration of Quality Control Criteria for Andrographis paniculate Products(Thai)

Abstract

Andrographolide is the main active constituent in Andrographis paniculata. However, the quality control of A. paniculata products is limited. A validated analytical method using HPLC was used for determination of andrographolide in A. paniculata products. The quality testing methods, adopted from the pharmacopoeias, USPXXVII and BP2002, were assay of andrographolide content, the uniformity of dosage unit and dissolution testing. Eight A. paniculata commercial products marketed in Thailand were used in this study. The content of andrographolide in dried powder form in the products ranged from 0.93 % to 3.01 % (%RSD 1.20 to 5.40). The uniformity of dosage unit was calculated in terms of mg andrographolide content per dosage unit which was between 2.96 and 11.35 mg (%RSD 3.49 to 10.34). The amount of andrographolide dissolved within 100 minutes per unit were 3.19 -11.19, 2.89-10.01 and 1.51-10.60 mg in 0.1 N hydrochloric acid solution, acetate buffer pH 4.5 and phosphate buffer solution pH 6.8, respectively. The results from stability testing indicated that the andrographolide content gradually decreased approximately 8-17% of the initial value in 3 months at ambient conditions and the degradation rate was much higher in accelerated condition.