Development and Validation of Fast and Sensitive RP-HPLC Stability-Indicating Method for Quantification of Piroxicam...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Piroxicam (PRXM) is a nonsteroidal anti-inflammatory drug (NSAID) requiring robust analytical methods for quality control.
• Existing methods may lack efficiency, sensitivity, or environmental friendliness.

Purpose of the Study:

• To develop and validate a simple, rapid, sensitive, and cost-effective green analytical method for piroxicam estimation.
• To assess the stability of piroxicam under various stress conditions.

Main Methods:

• Reverse-phase high-performance liquid chromatography (RP-HPLC) with a photodiode array (PDA) detector.
• Utilized a C-18 column and a mobile phase of methanol and 0.1% ortho-phosphoric acid (80:20 v/v).
• Method validation followed International Council for Harmonisation (ICH) Q2 (R1) guidelines, including linearity, precision, accuracy, and robustness. Stress degradation studies were performed per ICH Q1 (R2).

Main Results:

• The developed method demonstrated linearity over the concentration range of 50-300 μg mL-1 (R2 = 0.9995).
• Piroxicam showed significant degradation under acidic and basic conditions.
• The drug substance remained stable under oxidative, photolytic, and thermal stress conditions.

Conclusions:

• The green solvent-assisted RP-HPLC method is suitable for accurate and sensitive quantification of piroxicam.
• The method provides valuable insights into piroxicam's stability profile, crucial for pharmaceutical formulation and storage.