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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

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Development and validation of apalutamide-related substances method in solid dosage forms using HPLC.

Lova Gani Raju Bandaru¹, Naresh Konduru², Leela Prasad Kowtharapu³

¹Department of Chemistry, School of Science, GITAM (Deemed to be University) Hyderabad, Sangareddy, Telangana, India.

Biomedical Chromatography : BMC

|December 27, 2022

Summary

A new analytical method effectively separates and quantifies impurities in apalutamide tablets. This validated method ensures drug quality and stability for anticancer treatments.

Keywords:

HPLC apalutamide related substances validation and development

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis
Chromatography

Background:

Apalutamide is a crucial anticancer drug.
Ensuring the purity and stability of apalutamide formulations is vital for patient safety and therapeutic efficacy.
Development of a robust analytical method is necessary for quality control.

Purpose of the Study:

To develop and validate a related-substances method for apalutamide 60 mg tablets.
To ensure the accurate quantification of impurities and degradants.
To establish a stability-indicating method for routine quality control.

Main Methods:

High-Performance Liquid Chromatography (HPLC) with gradient elution.
Utilized a Luna Omega 5 μm Polar C18 column.
Detection at 225 nm with optimized mobile phase and temperature controls.

Main Results:

The method demonstrated excellent separation of impurities and degradants.
Validation confirmed high precision (RSD ≤ 1.84%), accuracy (96.0–106.3%), and linearity (r > 0.9999).
Method proved to be stable-indicating, robust, and compatible with common filters (Nylon, PTFE, PVDF).

Conclusions:

A validated, stability-indicating HPLC method for apalutamide related substances was successfully developed.
The method is suitable for routine quality control of apalutamide 60 mg tablets.
This contributes to ensuring the quality and safety of the anticancer drug.