Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF LORLATINIB IN BULK AND ITS PHARMACEUTICAL FORMULATION

Anuradha N. D.* and Syed Azhar Nizami

ABSTRACT

A Simple, Precise, Accurate and rapid liquid chromatography (RP-HPLC) method has been developed for the determination of Lorlatinib in bulk and in tablet dosage form. A reverse phase Eclipse plus C18 column (250mmX4.6mm,3μm) with mobile phase consisting of potassium dihydrogen orthophosphate, acetonitrile and methanol (50:30:20%V/V) having pH 4.2 was adjusted by using orthophosphoric acid. The flow rate was 1.0mL and effluents were monitored at 310nm. The Retention time of Lorlatinib was 7.871/min. The method was linear over the concentration range of 50 to 150μg/ml. The percentage mean recovery for Lorlatinib was observed to be 99% to 102% and the RSD was observed under 1%. The method was carried out based on International Conference on Harmonization (ICH) guidelines. The proposed technique was a new method of analysis for assessment of Lorlatinib drug substance by RP-HPLC method. And the method was observed to be appropriate for the standard examination of Lorlatinib in pure drug substance.

Keywords: Lorlatinib Acetonitrile, Methanol, validation, RP-HPLC.