Evaluation of thermal stability of indinavir sulphate using diffuse reflectance infrared spectroscopy.

Optical Radiation Standards, National Physical Laboratory, New Delhi, India.

Indinavir sulphate is a potent and specific protease inhibitor of human immunodeficiency virus (HIV). It is used for the treatment of acquired immune deficiency syndrome (AIDS). At elevated temperature the drug which otherwise remains crystalline undergoes a phase transition to an amorphous phase to form degradation products. In the present study, thermal stability of indinavir sulphate is evaluated using diffuse reflectance infrared Fourier transform (DRIFT) spectroscopy. Infrared spectra of the drug before and after the exposure to thermal radiation at different temperatures were acquired in the diffuse reflectance mode using a Fourier transform infrared (FTIR) spectrophotometer. The differential scanning calorimetry (DSC) and the X-ray diffraction (XRD) studies were used as complimentary techniques to adequately implement and assist the interpretation of the infrared spectroscopy results. The DRIFT spectra reveal that the drug remains stable up to 100 degrees C, degrades slightly at 125 degrees C and undergoes complete degradation at about 150 degrees C to produce degradation products. The degradation products can easily be characterized using the infrared spectra.

PMID: 18280078 [PubMed - indexed for MEDLINE]