Author:
Dandu Girija,Reddy Basu Venkateswara
Abstract
The present study describes the development and validation of a new stability indicating RP-HPLC method for simultaneous estimation of elbasvir and grazoprevir in bulk and pharmaceutical dosage form. The chromatographic separation was done by using reverse phase YMC column (4.6 x 250mm, 5μm).The mobile phase used was mixture of HPLC grade water acetonitrile (70:30V/V) at flow rate of 1ml/ min in isocratic mode and detection was carried out using PDA detector at 244nm.The developed method showed a good linearity in the range of 100-500μg/mL for elbasvir and 200-1000 μg/mL for grazoprevir with regression co-efficient of 0.999 for both the drugs. The % recovery of drugs was found to be 100.1% for elbasvir and 100.38% for grazoprevir. The proposed stability indicating method was accurate, precise, robust, stable and specific. The developed method was validated in accordance with ICH guidelines.
Publisher
Indian Drug Manufacturers' Association (IDMA)
Subject
Drug Discovery,Pharmaceutical Science,Pharmacology
Reference13 articles.
1. 1. Coburn C.A, Meinke P.T et al,Discovery of MK-8742 an HCV NS5A inhibitor with broad genotype activity. Chem Med Chem 2013, 8 1930–1940.
2. 2. Liu R, Curry S, McMonagle P, Yeh W.et al, Susceptibilities of genotype 1a, 1b, and 3HCV variants to the NS5A inhibitor elbasvir,Antimicrobial. Agents Chemotherapy pub med 2015, 59(11) 6922-9
3. 3. J. Guedj, H. Dahari, L.et al,, Proc.Modeling shows that the NS5A inhibitor daclatasvir has two modes of action and yields a shorter estimate of the hepatitis C virus half-life. Pub med 2013 5, 110(10) 3991-6.
4. 4. M. Gao, R.E. Nettleset al, Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect, Epub 2010, 465(7294) 2010, 96–100.
5. 5. National center for biotechnology Information. Pubchem compound Database, CID= 44603531.Available fromhtpp//pubchem.ncbi.nlm.gov/compound/ 44603531.