Quantification of Impurity-G Content in Levetiracetam Injection (100 mg/ml) by Using RP-HPLC Technique

Syed Mastan Ali

Acharya Nagarjuna University, Nagarjuna University, Guntur, A. P, India.

Ponnuri Bharath

Acharya Nagarjuna University, Nagarjuna University, Guntur, A. P, India.

V. Siva Ramakrishna

Acharya Nagarjuna University, Nagarjuna University, Guntur, A. P, India.

D. Ramachandran *

Acharya Nagarjuna University, Nagarjuna University, Guntur, A. P, India.

*Author to whom correspondence should be addressed.


Abstract

Extremely responsive technique for the quantification of impurity-G content in Levetiracetam samples by RP-HPLC method has been presented in the here manuscript. Quantification of impurity-G content in Levetiracetam sample by HPLC with UV Detector. Impurity-G was concluded by RP-HPLC technique by waters X-Terra MS-C18 (250 x 4.6mm, 5µm) column as motionless segment. Column oven preserved 45°C and taster cooler temperature 5°C, injection quantity 50µL, flow rate was 1.0 mL/min, impurity-G was detected using UV detector at the wavelength of 200nm and run time was 30 minutes. The movable segment utilized pH 3.0 buffer and acetonitrile in the proportion of (850:150 v/v) isocratic mode. The technique legalization has been carried as per International Conference on Harmonization guidelines (ICH). Limit of quantitation (LOQ) was found 0.4122 µg/mL for impurity-G.

Keywords: Impurity-G, Levetiracetam, RP-HPLC method, validation, limit of quantitation


How to Cite

Ali, S. M., Bharath, P., Ramakrishna, V. S. and Ramachandran, D. (2022) “Quantification of Impurity-G Content in Levetiracetam Injection (100 mg/ml) by Using RP-HPLC Technique”, Journal of Pharmaceutical Research International, 34(28B), pp. 53–61. doi: 10.9734/jpri/2022/v34i28B36035.