Establishment of inherent stability on piracetam by UPLC/HPLC and development of a validated stability-indicating method

Abstract

A novel comparative force degradation UPLC assay method was developed and validated for Piracetam and its degradation products. Piracetam was subjected to acid (5 M HCl), neutral (water) and alkaline (0.5 M NaOH) hydrolytic conditions at 80 °C, as well as to oxidative decomposition (H2O2) at room temperature. Photolytic studies were carried out by exposing this drug into sunlight (60,000–70,000 lux) for 2 d. Additionally, the solid drug was subjected to 50 °C for 60 days in a hot air oven for thermal degradation. The UPLC chromatographic separation was performed on Acquity UPLC BEH C18 column (1.7 μm, 2.1 mm × 150 mm) using isocratic mode (ACN:water, 25:75 v/v) at a flow rate of 0.15 mL min−1 and HPLC chromatographic separation was achieved on phenomenex C18 using isocratic mode (ACN:10 mM ammonium acetate, pH 5.0, 20:80 v/v) at a flow rate of 0.9 mL/min. Piracetam was found to degrade only in the base and shows stable behavior under all stress conditions. The UPLC and HPLC linearity of the proposed method was investigated in the range of 10–50 μg mL−1. The r2 value of UPLC and HPLC was found to be 0.999 and 0.999, respectively. Method detection limit (MDL) and Method quantification limit (MQL) were found to be 0.180 μg mL−1and 1.10 μg mL−1 for UPLC and 0.500 μg mL−1and 1.700 μg mL−1 for HPLC respectively. The %RSD values for intra-day and inter-day precision were <1.2%, confirming that the method was sufficiently precise. The validation studies were carried out fulfilling ICH requirements. The developed method was simple, fast, accurate and precise and hence could be applied for routine quality control analysis of Piracetam in solid dosage forms.

Keywords

• Piracetam
• Stress testing
• Stability indicating assay
• Validation
• UPLC
• HPLC