Determination of Purity and Uncertainty Evaluation of Bisacodyl by Differential Scanning Calorimetry

VernacularTitle:差示扫描量热法测定比沙可啶原料药纯度及不确定度评定
Author: Yonghui GUO ; Lijuan LYU ; Xuejing HAN ; Kai YAN
Publication Type:Journal Article
Keywords: Differential scanning calorimetry; HPLC; Bisacodyl; Uncertaint
From: China Pharmacy 2015;(18):2581-2582,2583
CountryChina
Language:Chinese
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.