Determination of Purity and Uncertainty Evaluation of Bisacodyl by Differential Scanning Calorimetry / 中国药房
China Pharmacy
; (12): 2581-2582,2583, 2015.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-605109
Responsible library:
WPRO
ABSTRACT
OBJECTIVE:
To establish the purity determination of bisacodyl by differential scanning calorimetry(DSC)and the valuation of uncertainty.METHODS:
DSC was conducted to detect the purity of bisacodyl and determine the optimal testing condi-tions. According to related standards,indium enthalpy change values,measurement repeatability,weighing process,instrument tem-perature deviation and system software deviation were systematically analyzed. The results were verified by HPLC.RESULTS:
When the fiducial probability P was 0.95,the standard value and uncertainty of content of bisacodyl was (99.88 ± 0.06)% mea-sured by DSC. Weighing process,instrument temperature deviation and system software deviation had great effects on the total un-certainty. The result of HPLC and DSC were the same.CONCLUSIONS:
The established DSC can quickly and accurately determine the chemical purity of bisacodyl. The uncertainty evaluation is reliable. Regularly calibrated and verificated equipment and strict con-trol of the weighing process will help to improve the accuracy measured by DSC;and it provides a new analysis method for the de-termination of purity of bisacodyl.
Full text:
Available
Database:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacy
Year:
2015
Document type:
Article