Abstract

“QbD APPROACH TO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PIRACETAM BY HPLC.”

Alifiya S. Rajkotwala*, Shaikh Sirajuddin S., Dr. Zarna R. Dedania, Dr. Ronak R. Dedania and Dr. S. M. Vijendraswamy

ABSTRACT

Piracetam, a derivative of the neurotransmitter γ-aminobutyric acid (GABA), has a variety of physiological effects that may result, at least in part, from the restoration of cell membrane fluidity. Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. A very useful component of the QbD is the understanding of factors and their interaction effects by a desired set of experiments. The present study describes the development of a comprehensive science and risk based HPLC method and subsequent validation for the analysis of Piracetam active pharmaceutical ingredient (API) using a quality by design approach. An efficient experimental design based on systematic scouting of two key components of the RP‐HPLC method (mobile phase and pH) is presented. The stock solution Piracetam was made in methanol and absorption maximum of standard solution of Piracetam was found be 205 nm. The chromatographic condition were optimized with design expert software 10.0 version, i.e; column C18, mobile phase used buffer (pH 6.5): Acetonitrile+0.1% TEA (80:20), flow rate was 1 ml/min. The described method was linear (r2 = 0.998) with range 20-70 μg/ml. The precision, ruggedness and robustness values were also within the prescribed limits (<1% for system precision and <2% for other parameters). Chromatographic peak purity results indicated the absence of co‐eluting peaks with the main peak of Piracetam. The proposed method can be used for routine analysis of Piracetam in quality control laboratories.

Keywords: Quality by design, HPLC, Piracetam, Design approach.