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Quality assessment of Siriraj Chantaleela recipe using high performance liquid

chromatography (HPLC)

1
1,2
1
1
Patcharamon Seubnooch , Jantanee Wattanarangsan , Pravit Akarasereenont , Sirikul Chotewuttakorn ,
2
1
Piyapat Pongnarin Prasopporn Punpeng , Tawee Laohapand 2
1 Department of Pharmacology, Center of Applied Thai Traditional Medicine, Faculty of Medicine,
2 Siriraj Hospital, Mahidol University, Bangkok 10700. Thailand.

Objective: To develop the fingerprint and parameters for quality assessment of Siriraj Chantaleela recipe
using High performance liquid chromatography (HPLC).

Material and Methods: Water extract of 3 batches of Siriraj Chantaleela solution (50 mg/ml) were

prepared for HPLC analysis (Thermo Separation Product with UV/vis detector and software system

controller SN4000). The separation was performed on a Phenomenex ODS column by adopted isocratic
mobile phase of methanol: 40 mM formic acid (25:75) at a flow rate of 0.8 ml/min. The absorption

wavelength was selected at 254 nm for 20 minutes. Peaks with percentage area of more than 5% were

selected to calculate relative peak area (RPA) and the relative retention time (RRT) to assess the precision
and repeatability of the test. Applied information content (phi) of each chromatogram was calculated to

demonstrate the similarity consistency among batches. The similarity will be validated if all parameters are

within the accepted ranged of 80-125% of mean and %CV of each parameter among batches is not more
than 10%.

Results: Five peaks were selected from the entire chromatogram and the third peak was used as the

reference peak because of the height and peak area stability. By relating to the reference peak, RRT and
RPA of 5 peaks were calculated and compared among the 3 batches. It was found that RRT and RPA of

3 batches of Siriraj Chantaleela were similar to each other with % CV less than 10 %. Phi value of 3

batches was also analyzed from the selected 5 peaks as well as from every peaks of each chromatogram.

Phi value, calculated from 5 peaks, were 0.443 + 0.019, 0.498 + 0.014 and 0.473 + 0.013 while calculated
from every peaks were 1.271 + 0.029, 1.233 + 0.019 and 1.286 + 0.016. They were all within the accepted

range of 0.377-0.589 and 1.011-1.516 with % CV of 5.8 % and 2.1 %.

Conclusion: Chromatogram fingerprints of 3 batches of Siriraj Chantaleela were successfully established.

RRT, RPA and phi among these 3 batches were similar and were within the accepted ranges with %CV
less than 10%. It, therefore, may suggest that the preparations from different batches of Siriraj Chantaleela

were consistent. Combination of RRT, RPA and phi are considered suitable parameters for quality

assessment.