Development of a validated RP-LC/ESI-MS-MS method for separation, identification and determination of related substances of tamsulosin in bulk drugs and formulations.

Abstract:

:A reversed-phase high performance liquid chromatographic (RP-HPLC) method for evaluation of purity of tamsulosin in bulk drugs and pharmaceuticals was developed. The separation was accomplished on an Inertsil C(18) column using 10 mM ammonium acetate: acetonitrile as a mobile phase in a gradient elution mode. A photodiode array detector set at 280 nm was used for detection. The impurities were identified by ESI-MS-MS. The detection limits were 0.06-0.11 microg/ml. The method was validated with respect to accuracy, precision, linearity, ruggedness and limits of detection and quantification. It finds application not only for monitoring the reactions during the process development but also on quality assurance of tamsulosin.

journal_name

J Pharm Biomed Anal

authors

Nageswara Rao R,Kumar Talluri MV,Narasa Raju A,Shinde DD,Ramanjaneyulu GS

doi

10.1016/j.jpba.2007.09.009

subject

Has Abstract

pub_date

2008-01-07 00:00:00

pages

94-103

issue

1

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(07)00515-8

journal_volume

46

pub_type

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