Summary

Qualitative and Quantitative Determination of Dexamethasone Acetate and Betamethasone Adulterated in Traditional Preparations by HPLC

Dexamethasone acetate (DA) and betamethasone (BTM) were used as adulterant drugs in traditional preparations for increasing effects. Some reports for identification of DA and BTM in traditional preparations by TLC were previously published. In this report, DA and BTM from traditional preparations were prepared by extracting with EtOAc, concentrating to residue and redissolving it with MeOH for HPLC analysis. The HPLC-PDA method was established with a high sensitivity to detect and quantify the small amounts of DA or BTM mixed in traditional preparations. The validation of the method met the requirements of sensitivity, linearrity, precision and accuracy. The linear regressision were acquired with r > 0.999. The concentrations determinated of DA and BTM ranged from 1 - 1000 μg/ml. RSD values were reported within < 5 %. The recovery was from 104 % to 109 %. LOD of DA and BTM were 0.5 μg/ml. LOQ of DA and BTM were 1.6 μg/ml. The process was applied to control two steroids in eight traditional preparations. The results showed that six of them containing corticoids. The contents of DA and BTM were detected in the range of 0.029 mg to 0.193 mg per gram of preparations.

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