ABSTRACT

The intention of current explore was to develop and validate suitable RP-HPLC method for analyzing Levetiracetam in single and combined dosage form as per ICH Guidelines. Separation was completed by using mobile phase consisting of HPLC grade water and acetonitrile in a proportion of 50:50. The separations were carried out on a Agilent Zorbax SB-Aq (250 x 4.6 mm, 5µ) at a flow rate of 1 mL/min. The injection volume was 10 µl and the peaks were detected at 205 nm. The calibration graph was plotted with concentration of the drug against the peak area was found to be linear in the range of 20- 30µg/ml and coefficient of correlation was found to be 0.9989. In the accuracy study of developed method the percentage recovery of levetiracetam ranging from 99.81-100.47.The %RSD value was less than 2.0 for intraday and interday precision indicated that the method was highly precise. Linearity range was observed in concentration range 20-30 µg/ml. The Limit of Detection and Limit of Quantitation was found to be 2.20µg/ml and 6.66µg/ml respectively. The system suitability parameters for the developed method found as, the average asymmetry factor found to be 0.992 which indicates asymmetric nature of peak. The average number of Theoretical plates was found to be 9154 which indicates efficient performance of the column. Hence, the developed RP-HPLC method was reliable, linear, accurate, specific method. Keywords: Levetiracetam, Accuracy, Precision, Estimation, Validation, Tablets, RP-HPLC
Publication date: 01/05/2022

https://ijbpas.com/pdf/2022/May/MS_IJBPAS_2022_6117.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.5.6117