10.22376/ijpbs.2019.10.1.p1-12 Volume 4 Issue 2 2013 (April - June) A new simple, accurate and sensitive HPLC pre-column derivatisation method for the low level determination of lessThan i greaterThan tert lessThan /i greaterThan -butylamine in Tigecycline drug substance has been developed. lessThan i greaterThan tert lessThan /i greaterThan -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 lessThan i greaterThan o- lessThan /i greaterThan phthalaldehyde (OPA) derivatisation technique. The method has been fully validated and the limit of detection & quantification for lessThan i greaterThan tert lessThan /i greaterThan -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. R.SRIKANTH, D.RAGHUNADHA REDDY AND C.S.VENKATESAN Pharmaceutical analysis, tert-butylamine, Amines, Tigecycline, HPLC pre-column derivatisation, RP-HPLC 522-531