Simplified process of candidate certified reference material development for the analysis of Andrographis paniculata derived therapeutics

Abstract Rapid procedure for the separation of andrographolide from Andrographis paniculata leaves was developed to furnish a certified reference material (CRM). Andrographolide is the principle compounds, which attributed to define the quality and efficacy of A. paniculata derived medicinal products. First time, authentication, sample preparation, homogeneity, storage stability, trueness and reliability assignment by uncertainty measurement of andrographolide by high performance liquid chromatography (HPLC) were illustrated in the present paper. The impurity in the samples due to residual moisture, inorganic and organic was determined by Karl-Fisher titration, thermogravimetric analysis, and differential scanning calorimetry methods, respectively. Following the EURACHEM/CITAC guide of CG-4 statistical procedure, the certified value and corresponding expanded uncertainty of andrographolide CRM was assigned to be 99.33% ± 0.02% (k=2) with one year stability (p