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to prepare the sample solutions for com- tion method described in THP, it has various

paring the extraction efficiency with that of drawbacks, such as time-consuming, labor-
reflux extraction method which is a standard intensive and multi-step process that requires
preparation method described in the THP. concentration by solvent evaporation before

According to ICH Q2(R1) Validation of chromatographic analysis. Long sample pre-
Analytical Procedures, change in sample paration times limit the number of samples,
preparation requires partial validation to en- and multi-step procedures are prone to intro-

sure that the analytical method maintains its duce errors and loss of analytes. The signi-
characteristics. Change in sample prepara- ficant advantages of ultrasonication over reflux

tion did not have an effect on the analytical method are reduction of organic solvent con-
method performance and data integrity as sumption, elimination of additional concen-
confirmed by validation results on speci- tration step and improvement in extraction

ficity, linearity, accuracy and precision. All efficiency. Therefore, ultrasound-assisted ex-
validated parameters were within the accep- traction is an attractive alternative to con-

tance criteria. ventional extraction techniques because it is
The contents of andrographolide ex- easy, inexpensive, fast and efficient. The pro-
tracted using ultrasonication were comparable posed sample preparation technique was also

and in most cases they are even higher than applied to determine the andrographolide
those obtained from reflux method. These content in Andrographis herbal materials as
results indicated that the extraction efficiency well as Andrographis extract capsules. It is

of reflux method using a mixture of methanol found that raw materials have satisfied quali-
and dichloromethane is not as efficient as ty in terms of andrographolide content (1.64-
that obtained from ultrasonication with 50% 2.14 %w/w) and the extract capsule contains

methanol. However, there were two samples andrographolide as high as 7.38 %w/w.
that reflux method gave higher content of
Conclusion
extracted andrographolide. These were fur-
ther investigated and it was found that the Two sample preparation techniques
particle sizes of sample powder were not were compared in this study. The results

uniform even they were finely ground and clearly indicated that ultrasonication was
sieved through mesh size No.180, small stem better than reflux extraction method because

parts were also observed. Although reflux it provides higher extraction efficiency, was
extraction is the standard sample prepara- more economical, more convenient, easily