Physical-chemical characterization and polymorphism determination of two nimodipine samples deriving from distinct laboratories

Drug Dev Ind Pharm. 2005 Aug;31(7):631-7. doi: 10.1080/03639040500216212.

Abstract

Knowing the characteristics of raw materials in pharmaceutical practice is both important and useful. Firstly, evaluating the physical-chemical properties of the substances that will be used must be the primary step for quality control in the pharmacy industry. This work aims at analyzing the physical-chemical characteristics of two nimodipine samples I and II derived from distinct laboratories through thermal analysis (DSC and TG/DTG), HPLC, crystallography, and microscopy. Thermal analysis showed that sample II was more unstable than I. Morphological differences concerning shape, size, and crystallinity of particles were visualized by scanning electron microscopy (SEM) and X-ray powder diffraction. To sum up, the techniques used in this study can be said to have been efficient in the characterization and evaluation of quality control of the raw material.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Calcium Channel Blockers / chemistry*
  • Calorimetry, Differential Scanning
  • Chromatography, High Pressure Liquid
  • Crystallization
  • Drug Stability
  • Microscopy, Electron, Scanning
  • Nimodipine / chemistry*
  • Powder Diffraction
  • Quality Control
  • Thermogravimetry
  • Transition Temperature
  • X-Ray Diffraction

Substances

  • Calcium Channel Blockers
  • Nimodipine