PMID- 22795312
OWN - NLM
STAT- MEDLINE
DCOM- 20130207
LR  - 20191210
IS  - 1873-264X (Electronic)
IS  - 0731-7085 (Linking)
VI  - 70
DP  - 2012 Nov
TI  - Polymorphism in nimodipine raw materials: development and validation of a 
      quantitative method through differential scanning calorimetry.
PG  - 188-93
LID - S0731-7085(12)00361-5 [pii]
LID - 10.1016/j.jpba.2012.06.029 [doi]
AB  - Due to the physical-chemical and therapeutic impacts of polymorphism, its 
      monitoring in raw materials is necessary. The purpose of this study was to 
      develop and validate a quantitative method to determine the polymorphic content 
      of nimodipine (NMP) raw materials based on differential scanning calorimetry 
      (DSC). The polymorphs required for the development of the method were 
      characterized through DSC, X-ray powder diffraction (XRPD) and Raman spectroscopy 
      and their polymorphic identity was confirmed. The developed method was found to 
      be linear, robust, precise, accurate and specific. Three different samples 
      obtained from distinct suppliers (NMP 1, NMP 2 and NMP 3) were firstly 
      characterized through XRPD and DSC as polymorphic mixtures. The determination of 
      their polymorphic identity revealed that all samples presented the Modification I 
      (Mod I) or metastable form in greatest proportion. Since the commercial polymorph 
      is Mod I, the polymorphic characteristic of the samples analyzed needs to be 
      investigated. Thus, the proposed method provides a useful tool for the monitoring 
      of the polymorphic content of NMP raw materials.
CI  - Copyright (c) 2012 Elsevier B.V. All rights reserved.
FAU - Riekes, Manoela Kluppel
AU  - Riekes MK
AD  - Post Graduate Program in Pharmacy, Federal University of Santa Catarina, 
      Florianopolis, SC 88040-970, Brazil. manoelakr@hotmail.com
FAU - Pereira, Rafael Nicolay
AU  - Pereira RN
FAU - Rauber, Gabriela Schneider
AU  - Rauber GS
FAU - Cuffini, Silvia Lucia
AU  - Cuffini SL
FAU - de Campos, Carlos Eduardo Maduro
AU  - de Campos CE
FAU - Silva, Marcos Antonio Segatto
AU  - Silva MA
FAU - Stulzer, Hellen Karine
AU  - Stulzer HK
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20120630
PL  - England
TA  - J Pharm Biomed Anal
JT  - Journal of pharmaceutical and biomedical analysis
JID - 8309336
RN  - 0 (Calcium Channel Blockers)
RN  - 57WA9QZ5WH (Nimodipine)
SB  - IM
MH  - Analysis of Variance
MH  - Calcium Channel Blockers/*chemistry
MH  - Calibration
MH  - *Calorimetry, Differential Scanning/standards
MH  - Crystallization
MH  - Crystallography, X-Ray
MH  - Limit of Detection
MH  - Linear Models
MH  - Nimodipine/*chemistry
MH  - Powder Diffraction
MH  - Reproducibility of Results
MH  - Spectrum Analysis, Raman
EDAT- 2012/07/17 06:00
MHDA- 2013/02/08 06:00
CRDT- 2012/07/17 06:00
PHST- 2012/02/28 00:00 [received]
PHST- 2012/06/06 00:00 [revised]
PHST- 2012/06/20 00:00 [accepted]
PHST- 2012/07/17 06:00 [entrez]
PHST- 2012/07/17 06:00 [pubmed]
PHST- 2013/02/08 06:00 [medline]
AID - S0731-7085(12)00361-5 [pii]
AID - 10.1016/j.jpba.2012.06.029 [doi]
PST - ppublish
SO  - J Pharm Biomed Anal. 2012 Nov;70:188-93. doi: 10.1016/j.jpba.2012.06.029. Epub 
      2012 Jun 30.