A dual system of CDs was used for the first time in MEEKC with the aim of determining clemastine and its three main related impurities in both drug substances and tablets. The addition of methyl-b-cyclodextrin and heptakis(2,6-di-O-methyl)-b-cyclodextrin to the microemulsion pseudo-stationary phase was essential to increase the resolving power of the system to obtain a baseline separation among the compounds. The best microemulsion composition was identified by mixture design and the effects of the factors concentrations of CDs and voltage were investigated by a response surface study applying a Central Composite Design. In both cases, Derringer’s desirability function made it possible to find the global optimum, which corresponded to the following combination: microemulsion, 89.8% 10mM borate buffer pH 9.2, 1.5% n-heptane and 8.7% of SDS/nbutanol in 1:2 ratio; 18mM methyl-b-cyclodextrin, 38mM heptakis(2,6-di-O-methyl)-bcyclodextrin, 17 kV. By applying these conditions, the separation was completed in about 5.5 min. The method was validated following International Conference on Harmonisation guidelines and was applied to a real sample of clemastine tablets.

Dual CD system-modified MEEKC method for the determination of clemastine and its impurities / S. Orlandini; I. Giannini; M. Villar Navarro; S. Pinzauti; S. Furlanetto. - In: ELECTROPHORESIS. - ISSN 0173-0835. - STAMPA. - 31:(2010), pp. 3296-3304. [10.1002/elps.201000066]

Dual CD system-modified MEEKC method for the determination of clemastine and its impurities.

ORLANDINI, SERENA
;
GIANNINI, IACOPO;PINZAUTI, SERGIO;FURLANETTO, SANDRA
2010

Abstract

A dual system of CDs was used for the first time in MEEKC with the aim of determining clemastine and its three main related impurities in both drug substances and tablets. The addition of methyl-b-cyclodextrin and heptakis(2,6-di-O-methyl)-b-cyclodextrin to the microemulsion pseudo-stationary phase was essential to increase the resolving power of the system to obtain a baseline separation among the compounds. The best microemulsion composition was identified by mixture design and the effects of the factors concentrations of CDs and voltage were investigated by a response surface study applying a Central Composite Design. In both cases, Derringer’s desirability function made it possible to find the global optimum, which corresponded to the following combination: microemulsion, 89.8% 10mM borate buffer pH 9.2, 1.5% n-heptane and 8.7% of SDS/nbutanol in 1:2 ratio; 18mM methyl-b-cyclodextrin, 38mM heptakis(2,6-di-O-methyl)-bcyclodextrin, 17 kV. By applying these conditions, the separation was completed in about 5.5 min. The method was validated following International Conference on Harmonisation guidelines and was applied to a real sample of clemastine tablets.
2010
31
3296
3304
S. Orlandini; I. Giannini; M. Villar Navarro; S. Pinzauti; S. Furlanetto
File in questo prodotto:
File Dimensione Formato  
2010_Orlandini-S._Electrophoresis.pdf

Accesso chiuso

Tipologia: Altro
Licenza: Tutti i diritti riservati
Dimensione 369.32 kB
Formato Adobe PDF
369.32 kB Adobe PDF   Richiedi una copia

I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/385766
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 18
  • ???jsp.display-item.citation.isi??? 16
social impact