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

AbstractA novel comparative force degradation UPLC assay method was developed and validated for Piracetam and its degradation products. Piracetam was subjected to acid (5M HCl), neutral (water) and alkaline (0.5M 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 (60,000–70,000lux) for 2d. Additionally, the solid drug was subjected to 50°C for 60days in a hot air oven for thermal degradation. The UPLC chromatographic separation was performed on Acquity UPLC BEH C18 column (1.7μm, 2.1mm×150mm) using isocratic mode (ACN:water, 25:75 v/v) at a flow rate of 0.15mLmin−1 and HPLC chromatographic separation was achieved on phenomenex C18 using isocratic mode (ACN:10mM ammonium acetate, pH 5.0, 20:80 v/v) at a flow rate of 0.9mL/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 10–50μgmL−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 0.180μgmL−1and 1.10μgmL−1 for UPLC and 0.500μgmL−1and 1.700μgmL−1 for HPLC respectively. The %RSD values for intra-day and inter-day precision were