Comparison of high sensitivity micro differential scanning calorimetry with X-ray powder diffractometry and FTIR spectroscopy for the characterization of pharmaceutically relevant non-crystalline materials.
In this study, high sensitivity micro differential scanning calorimetry (MDSC) in the scanning of dynamic mode was compared to X-ray powder diffractometry (XRPD) for quantifying amorphous nifedipine in mixtures crystalline nifedipine. This technique was also compared with FTIR for quantifying polymorph A of chloramphenicol palmitate (CAP) and poly DL-lactide-co-glycolide) (PLGA) in pharmaceutical formulations. The limit of determination (LOD) achieved by MDSC were 0.06% compared to 5% for XRPD quantification of amorphous nifedipine and 0.02% compared to 7% for IR quanitfication of polymorph A of CAP. As little as 0.165 mg PLGA could be measured in excipients mixtures. Desirable linearity and repeatability were established in all cases.
Song
M
M
Department of Basis Pharmaceutical Sciences, School of Pharmacy, Universität of Louisiana at Monroe LA 71209, USA.
Liebenberg
W
W
De Villiers
M M
MM
D002152:Calorimetry, Differential Scanning; D002626:Chemistry, Pharmaceutical; D002701:Chloramphenicol / Q000737:chemistry; D003460:Crystallization; D019344:Lactic Acid; D009543:Nifedipine / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011100:Polyglycolic Acid; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011108:Polymers; D015203:Reproducibility of Results; D017550:Spectroscopy, Fourier Transform Infrared; D014961:X-Ray Diffraction
D004364:Pharmaceutical Preparations; D011108:Polymers; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D002701:Chloramphenicol; D009543:Nifedipine