Determination of Mannityl Nicotinate API by DSC / 中国药师

ABSTRACT

Objective:To establish a DSC method for the determination of mannityl nicotinate. Methods:Indium was used to cor-rect the instrument including temperature correction and heat flow correction. The atmosphere was nitrogen and the flow rate was 20 ml ·min-1 . The sample volume was 1-3. 5 mg with precision reached to 0. 01mg. The initial temperature was 30 ℃, raised to 120 ℃ at the rate of 10℃·min-1 , maintaining for 1 min at 120℃, and raised to 280℃ at the rate of 2. 5℃·min-1 . The results of DSC and HPLC were compared. Results:Mannityl nicotinate had a good linear relationship between the heat absorption and the amount of sam-ple within the range of 1. 05-3. 44 mg (r=0. 9990). The average recovery was 98. 86％ (RSD=1. 59％,n=9). The content of nia-cin detected by HPLC and DSC was 97. 77％ and 97. 80％, respectively, and the relative mean deviation of the two values was 0. 015％. Conclusion:The DSC method is accurate and rapid, and can be used for the determination of mannityl nicotinate like HPLC.