Show simple item record

dc.creatorZečević, Mira
dc.creatorStanković, Z
dc.creatorŽivanović, L
dc.creatorJocić, B
dc.date.accessioned2019-09-02T11:06:47Z
dc.date.available2019-09-02T11:06:47Z
dc.date.issued2006
dc.identifier.issn0021-9673
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/815
dc.description.abstractThe novel, rapid high performance liquid chromatographic method for the determination of tramadol hydrochloride and its three impurities was developed and validated. The method can simultaneously assay potassium sorbate, used as preservative. and saccharin sodium, used as sweetener in tramadol pharmaceutical formulation. The separation was carried out on a C-18 XTerra (TM) (150 mm x 4.6 mm, 5 mm) column using acetonitrile-0.015 M Na2HPO4 buffer (2:8, v/v) as mobile phase (pH value 3.0 was adjusted with orthophosphoric acid) at a flow rate 1.0 ml min(-1), temperature of the column 20 degrees C and UV detection at 218 nm. The method was found to be linear (r > 0.999) in the range of 0.05-0.8 mg ml(-1) for tramadol hydrochloride, 0.1-1.2 mg ml(-1) for impurities B and C and for impurity A (r > 0.995) in the range 0.15-2.4 mg ml(-1). The low RSD values indicate good precision and high recovery values indicate excellent accuracy of the HPLC method. Developed method was successfully applied to the determination of tramadol hydrochloride. its investigated impurities and potassium sorbate in commercial formulation. The recovery of tramadol hydrochloride was 98.25% and RSD was 1.80%. The method is rapid and sensitive enough to be used to analyse Trodon((R)) oral drops.en
dc.publisherElsevier Science BV, Amsterdam
dc.rightsrestrictedAccess
dc.sourceJournal of Chromatography A
dc.subjectcolumn liquid chromatographyen
dc.subjectreversed phaseen
dc.subjecttramadol hydrochloride bulk drug and oral dropsen
dc.subjectpotassium sorbateen
dc.titleValidation of a high-performance liquid chromatographic method for the simultaneous determination of tramadol and its impurities in oral drops as a pharmaceutical formulationen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractЗечевић, Мира; Јоцић, Б; Живановић, Л; Станковић, З;
dc.citation.volume1119
dc.citation.issue1-2
dc.citation.spage251
dc.citation.epage256
dc.citation.other1119(1-2): 251-256
dc.citation.rankaM21
dc.identifier.wos000238707100035
dc.identifier.doi10.1016/j.chroma.2005.11.105
dc.identifier.pmid16386751
dc.identifier.scopus2-s2.0-33744786235
dc.identifier.rcubconv_1726
dc.type.versionpublishedVersion


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record