DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE QUANTIFICATION OF PIRACETAM AND MECOBALAMIN
The analysis of Piracetam and Mecobalamin by improved High Performance liquid chromatography method with UVdetector and data handling system is investigated. Piracetam is a medicine which is used in Myoclonus. Piracetam may enhance, elevate, and improve cognitive functions and abilities linked and associated to the central nervous system, memory development and memory processes. Methylcobalamin is also used in the treatment of peripheral neuropathy, diabetic neuropathy, and as a preliminary treatment for amyotrophic lateral sclerosis. The improved HPLC-UV detector method for the separation and quantification of Piracetam and Mecobalamin is described. Samples are analyzed by means of reverse phase(RP) HPLC using a Waters C18 column (250x4.6mm,5µm particle size) ,and the mobile phase used as potassium dihydrogen phosphate buffer of pH adjusted to 6.0 with o-phosphoric acid(A) and Acetonitrile(B) and methanol(C) A: B :C ratio was 40:50:10 v/v and the flow rate is 1 ml/min. The column temperature is set at ambient temperature and wavelength fixed at 251nm using PDA detector. The described method of Piracetam is linear over a range of 20μg/ml to 80 μg/ml and Mecobalamin in range of 0.025-0.1μg/ml. The method precision for the determination of assay was below 2.0%RSD. The percentage recoveries of Active pharmaceutical ingredient (API) from dosage forms ranged from 98%-102%. The method is useful in the quality control of pharmaceutical formulations. This provides a complete separation and determination of Piracetam and Mecobalamin. It is found that the method of RP-HPLC with PDA detector for the analysis of Piracetam and validation study compared as per ICH guideline.