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, A.P- 517102.
A B S T R A C T
The author developed RP-HPLC method for the determination of the impurities of Voriconazole with adequate resolution in Voriconazole Injection. The current official USP monograph uses two methods for the determination of Voriconazole impurities in Voriconazole Injection and the resolution between impurities Retention time Impurity- RRT at Impurity-C (0.43), impurity–D (0.52) is not appropriate. The analytical method uses inertsil ODS-3V 250-mm x 4.6 mm, 5 µm, (or) Equivalent column and the mobile phase consists of Sodium Dihydrogen Phosphate, water and ACN adjusted the pH with diluted ortho phosphoric acid with a column temperature at the injection volume To finalize the above chromatographic conditions. pH condition of the mobile phase was optimized with different pH. To improve the retention time and resolution for impurity C and Impurity-D ion pairing reagent was introduced in the mobile phase by using the chemicals & reagents in AR Grade. (Sodium Dihydrogen Phosphate). By Using Filter Membrane 0.45 µm nylon membrane filter and degas to separate the Impurities By using Auto Sampler Equipment. And Calculate the Potency of Working Standard As is Basis, Relative Response Factor and add the Label claim.
Keywords: Voriconazole, Impurity-C, Impurity- D, HPLC, pH, Membrane Filter