Method development and validation by Gas chromatography-HeadSpace - Couverture souple

Mishra, Garima; Srivastava, Vikas Kumar

 
9783659492914: Method development and validation by Gas chromatography-HeadSpace
Couverture souple
ISBN 10 : 3659492914 ISBN 13 : 9783659492914
Editeur : LAP LAMBERT Academic Publishing, 2013

Synopsis

Residual solvents in pharmaceutical samples are monitored using gas chromatography with head space. Based on good manufacturing practices, measuring residual solvents is mandatory for the release testing of all active pharmaceutical ingredients (API). The analysis of residual organic solvents (methanol, ethanol, acetone and toluene) in Omeprazole API was investigated.The Head space gas chromatography (HSGC) method described in this investigation utilized a DB - 624, 30 m long x 0.32 mm internal diameter, 1.8 μm thick column. Since Omeprazole is a thermally labile compound, the selection of the proper injector temperature is critical to the success of the analysis. The injector temperature was set at 180°C to prevent degradation. The initial oven temperature was set at 50°C for 10 min and programmed at a rate of 30°C min−1 to a final temperature of 200°C for 10 min. Nitrogen was used as a carrier gas and flame ionization detector was used. N,N-dimethyl formamide was selected as a diluent. The method was validated according to ICH guidelines and found to be specific, linear i.e.,C.C is 0.998,% RSD of each analyte is less than 8%, sensitive, rugged and showed excellent recovery.

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L'autore

The author is Garima Mishra D/o Kashi Prasad Mishra, has completed her B.Pharm (2006-2010) from Lloyd institute of management and technology, Gr. Noida with 75.3%. She has completed M.Pharma (Pharmaceutical Chemistry) from I.T.S Paramedical (Pharmacy) college,Ghaziabad, affiliated to MahaMaya Technical University, Noida with 76%.

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Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2013
Langue
anglais
ISBN 10 
3659492914
ISBN 13 
9783659492914
Reliure
Copertina flessibile
Nombre de pages
96
Coordonnées du fabricant
non disponible
Personne responsable
KreGa Onlinehandel GmbH
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