Cleaning validation: quantitative estimation of atorvastatin in production area

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry

Background:

• Cleaning validation is crucial in pharmaceutical manufacturing to prevent cross-contamination.
• Active pharmaceutical ingredient (API) residues must be quantified to ensure equipment safety for subsequent products.

Purpose of the Study:

• To develop and validate UV spectrophotometric and TOC-SSM methods for atorvastatin residue determination.
• To confirm the efficiency of cleaning procedures in pharmaceutical production areas.

Main Methods:

• Atorvastatin was selected as a worst-case scenario API for residue analysis.
• UV spectrophotometric and TOC-SSM methods were developed and validated according to ICH guidelines.
• Residue quantification was performed on spiked stainless steel plates and production equipment surfaces.

Main Results:

• Both methods demonstrated good linearity, with acceptable limits of detection and quantitation.
• Percentage recovery for spiked samples was high (95.37% for UV, 92.82% for TOC-SSM).
• Atorvastatin residues were consistently found below the acceptance limit after cleaning procedures.

Conclusions:

• The validated UV spectrophotometric and TOC-SSM methods are suitable for accurate and precise quantification of atorvastatin residues.
• These methods are cost-effective, simple, and less time-consuming for cleaning validation in pharmaceutical industries.
• The established methodology ensures the efficiency of cleaning procedures and prevents cross-contamination.