METHOD DEVELOPMENT AND VALIDATION OF LORLATINIB BY USING RP-HPLC

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Dr. Subhas Sahoo , Dr. S.Srinivasa Rao, G.Mounika

In the research analysis a rapid, accurate and reliable High Performance Liquid Chromatography (HPLC) method was developed and validated by selecting chromatographic parameters for estimation of Lorlatinib in pharmaceutical dosage forms. The HPLC method was developed using reverse phase Zorbax bonus C18 column with Acetonitrile and Trifluoroacetic acid (100:0.10) as mobile phase. The flow rate was 1.0 ml / min with PDA detection at λ max 245 nm and the injection volume was set at 10ml with 25 min run time. This method has been validated by the use of different validation parameters such as accuracy, precision, linearity, lod and loq. Such findings showed that the system could find practical use in its tablet dosage forms as a quality assurance tool for evaluating the drug in pharmaceutical industries.

Method development, Validation, Lorlatinib, RP-HPLC