Optimization and Validation for Simultaneous Estimation of Citicoline and Piracetam in Bulk and Tablet Formulations Using RP-HPLC Method:Analytical Quality by Design Approach

The present work describes a reversed phase high performance liquid chromatographic method for simultaneous estimation of Citicoline (CIT) and Piracetam (PIR) in bulk as well as tablet dosage forms. The estimation was carried out on a C₁₈ column using mobile mixture of acetonitrile and 10 mM disodium hydrogen phosphate buffer in the ratio of 10:90 (v/v) as a mobile phase. All analytes were detected by measuring the absorbance at 205 nm with flow rate of 1.0 ml/min. The total run time of the study was 16 min. for complete separation of both drugs. The elution was achieved at the retention times of 3.79 and 13.08 min for Citicoline, and Piracetam, respectively. The method was validated for accuracy, precision, linearity, specificity and sensitivity as per ICH norms. The calibration curves were found linear over the concentration ranges of 4-40μg/mL for Citicoline and 5-50μg/mL for Piracetam. From the validation study it was found that the method is specific, rapid, accurate and precise.