Stability indicating reverse phase high performance liquid chromatography method for the estimation of capsaicin

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences

Background:

• Stability-indicating methods (SIMs) are crucial for assessing drug degradation and ensuring product quality.
• The Food and Drug Administration (FDA) mandates validated SIMs for stability studies of active pharmaceutical ingredients (APIs).

Purpose of the Study:

• To develop a simple, precise, and accurate stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) assay for capsaicin (CAP).
• To analyze CAP at concentrations ranging from 70 to 130 μg/mL.

Main Methods:

• Utilized HPLC with a Photo diode Array (PDA) detector and an ODS (250 × 4.6 mm, 5 μm) column.
• Employed a mobile phase of Acetonitrile:water:buffer (75:10:15) with a 1 mL/min flow rate, monitoring at 280 nm.
• Validated the method for linearity, limit of detection (52.9 ng/mL), limit of quantification (160 ng/mL), and precision (RSD < 2%).

Main Results:

• Achieved successful chromatographic separation of CAP and its potential degradants under various stress conditions (alkaline, thermal, photodegradation).
• Demonstrated method accuracy and precision, with no observed interferences from impurities or excipients.
• Recovery studies confirmed the method's utility in analyte recovery.

Conclusions:

• The developed RP-HPLC method is suitable for the successful separation and quantification of CAP and its potential degradants in bulk and pharmaceutical formulations.
• UV spectra of degradants can aid in understanding CAP degradation pathways under environmental conditions.