Dr. Srinivas Jagarlapudi*1, A. Ravi Kumar2, Panchumarthi Srinivas2, M. Raveendra Babu2, P. Ramyasree2
1Sri Krishnadevaraya University, Anatapuramu. Andhra Pradesh, India-515003.
2Sree Vidyanikethan College of Pharmacy, Sree Sainath Nagar, Tirupathi, A. Ranganpet, Andhra Pradesh-517102.
A B S T R A C T
The author developed a novel and unique RP-HPLC method for the determination of all the impurities of Ondansetron with adequate resolution in Ondansetron Injection.The current official USP monograph uses two methods for the determination of Ondansetron impurities in Ondansetron Injection and the resolution between impurity E (imidazole) and impurity F (2-methyl imidazole) is not appropriate. The analytical method uses a Zodiac C18 (250 x 4.6 mm, 3 µm) column and the mobile phase consists of 1-octane sulfonic acid (ion pair), water and adjusted the pH to 2.5 with diluted ortho phosphoric acid with a column temperature of 30°C and injection volume of 25 µL. To finalize the above chromatographic conditions several C18 stationary phases were used. pH condition of the mobile phase was optimized with different pH. To improve the retention time and resolution for impurity E and Impurity-F ion pairing reagent was introduced in the mobile phase. Gradient elution mode was selected for the separation all known and degradants impurities from the analyte peak. The analytical validation covered all the parameters including robustness.
Keywords: Ondansetron injection, Development, Validation, Gradient, Stationary phase, HPLC, ion-pair.