Determination of the melting temperature, heat of fusion, and purity analysis of different samples of zidovudine (AZT) using DSC

作者：Souza Araujo Adriano Antunes; Bezerra Marilia dos Santos; Storpirtis Silvia; Matos Jivaldo do Rosario

来源：Brazilian Journal of Pharmaceutical Sciences, 2010, 46(1): 37-43.

• Zidovudine/purity determination
• Differential scanning calorimetry
• Thermal analysis
• Medicines/quality control
• Medicines/qualitative analysis

The determination of chemical purity, melting range, and variation of enthalpy in the process of characterizing medicines is one of the principal requirements evaluated in quality control of the pharmaceutical industry. In this study, the method of purity determination using DSC was outlined, as well as the application of this technique for the evaluation of commercial samples of zidovudine (AZT) (raw material) supplied by different laboratories. To this end, samples from six different laboratories (A, B, C. D, E, and F) and the standard reference (R) from the United States Pharmacopeia (USP) were analyzed. The DSC curves were obtained in the temperature range of 25 to 200 degrees C under the dynamic atmosphere of N(2) (50 mL min(-1)), heating rate of beta=2 degrees C min(-1), using an Al capsule containing approximately 2 mg of sample material. The results demonstrated that the standard reference presented a proportion of 99.83% whereas the AZT samples presented a variation ranging from 97.59 to 99.54%. In addition, the standard reference was found to present a temperature of onset of melting point of 122.80 degrees C. Regarding the samples of active agents provided by the different laboratories, a variation ranging from 118.70 to 122.87 degrees C was measured. In terms of Delta H(m), the samples presented an average value of 31.12 kJ mol(-1.)

• 出版日期2010-3