METHOD DEVELOPMENT AND VALIDATION OF MONTELUKAST BY USING LC-MS MS

B. Parijatha*, A. Sahithi, D. Santhoshi Priya, D. Suchitra and Krishnamohan Chinnala

ABSTRACT

High performance liquid chromatography mass spectrometric method in positive ion mode for the estimation of Montelukast in human plasma was developed and validated using Montelukast D6 as internal standard (ISTD). Sample preparation was accomplished by solid phase extraction technique. The eluted samples were chromatographed on ZORBAX Eclipse XDB phenyl 4.6*75 mm, 3.5 μm column (Agilent Technologies) using a mobile phase consisting of acetonitrile: 5 mM ammonium acetate (85:15 v/v). The method was validated over a concentration range of 5.032 ng/mL to 602.362 ng/mL for Montelukast. This validation report provides the results of selectivity, matrix effect. Sensitivity determinations, calibration standards and quality control samples data, precision and accuracy data, and dilution integrity along with all pertinent supporting documentation.

Keywords: Montelukast, Reverse phase HPLC, Solid phase extraction technique, Method development, Method Validation.