Drug Content Uniformity: Quantifying Loratadine in Tablets Using a Created Raman Excipient Spectrum

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Spectroscopy

Background:

• Raman spectroscopy is vital for drug analysis and counterfeit detection.
• Accurate quantification of active pharmaceutical ingredients (APIs) is crucial for drug quality control.
• Existing methods for API quantification often require detailed knowledge of inactive ingredients (excipients).

Purpose of the Study:

• To develop a simplified Raman spectroscopy method for determining API mass percent in pharmaceutical products.
• To assess the method's capability in evaluating batch quality against US Pharmacopeia content uniformity standards.
• To demonstrate the method's applicability without prior knowledge of excipient identities or quantities.

Main Methods:

• Developed a method using Raman spectra fitting to quantify loratadine (API) in Claritin tablets.
• Validated the method by comparing results with high-performance liquid chromatography (HPLC).
• Applied the method to generic formulations with unknown excipients, creating a composite excipient spectrum.

Main Results:

• The Raman spectroscopy method accurately determined loratadine mass percent in branded and generic tablets.
• Results showed favorable comparison with HPLC, with both methods meeting US Pharmacopeia acceptance values.
• The method successfully passed or failed manufactured drug product batches based on content uniformity criteria.

Conclusions:

• This simple Raman spectroscopy method enables API mass percent determination without excipient knowledge.
• The technique provides a reliable approach for assessing pharmaceutical batch quality and content uniformity.
• The method offers a practical alternative for drug quality control, aligning with regulatory standards.