DEVELOPMENT AND VALIDATION OF RP-HPLC PRE-COLUMN DERIVATISATION FOR THE TRACE LEVEL DETERMINATION OF TERTBUTYLAMINE IN TIGECYCLINE DRUG SUBSTANCE

Authors

  • R.SRIKANTH Analytical R&D, Gland Pharma Limited, Hyderabad-500 043, India
  • D.RAGHUNADHA REDDY Analytical R&D, Gland Pharma Limited, Hyderabad-500 043, India
  • C.S.VENKATESAN Analytical R&D, Gland Pharma Limited, Hyderabad-500 043, India

Keywords:

Pharmaceutical analysis, tert-butylamine, Amines, Tigecycline, HPLC pre-column derivatisation, RP-HPLC

Abstract

A new simple, accurate and sensitive HPLC pre-column derivatisation method for the low level determination of tert-butylamine in Tigecycline drug substance has been developed. tert-butylamine may be present at a trace level in the Tigecycline drug substance, which is used as a reagent in the manufacturing process of Tigecycline. Chromatographic separations were accompanied under isocratic conditions using a Shimadzu HPLC with UV detection and a simple o-phthalaldehyde (OPA) derivatisation technique. The method has been fully validated and the limit of detection & quantification for tert-butylamine were 2.8ppm & 8.5ppm respectively. The method was linear over the range (8.5 – 1561µg/mL, n=7, r = 0.99993) of the working sample concentration of 20mg/mL. The precision, accuracy and ruggedness of the method are presented.

Downloads

Published

30.06.2013

How to Cite

R.SRIKANTH, D.RAGHUNADHA REDDY, & C.S.VENKATESAN. (2013). DEVELOPMENT AND VALIDATION OF RP-HPLC PRE-COLUMN DERIVATISATION FOR THE TRACE LEVEL DETERMINATION OF TERTBUTYLAMINE IN TIGECYCLINE DRUG SUBSTANCE. International Journal of Pharma and Bio Sciences, 4(2), 522–531. Retrieved from https://ijpbs.net/index.php/journal/article/view/2199

Issue

Volume 4, Issue 2, 2013

Section

Research Articles

Categories