Method Development and Validation of Lorlatinib by RP-HPLC.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Lorlatinib is an important pharmaceutical compound.
• Accurate quantification of Lorlatinib is crucial for quality control.

Purpose of the Study:

• To develop and validate a simple, accurate, and precise analytical method for Lorlatinib estimation.
• To establish a method suitable for routine quality control in pharmaceutical industries.

Main Methods:

• Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) was employed.
• Analysis utilized a Hypersil C18 column with a mobile phase of Methanol and Water (25:75% v/v).
• Optimized conditions included a flow rate of 1.0 ml/min, 38°C column temperature, and 310 nm detection wavelength.

Main Results:

• The method demonstrated good linearity, accuracy, and precision, with %RSD within acceptable limits.
• The %Recovery for Lorlatinib was found to be 98.96%.
• Limit of Detection (LOD) and Limit of Quantitation (LOQ) were determined as 0.332 µg/ml and 1.0078 µg/ml, respectively.

Conclusions:

• The developed RP-HPLC method is simple, accurate, precise, and economical for Lorlatinib estimation.
• The method's reduced retention and run times make it ideal for regular quality control in pharmaceutical industries.