Chemometrically Assisted RP-HPLC and Spectroscopic Method Development for Simultaneous Multi-Component Analysis of Ledipasvir and Sofosbuvir in Pure and Pharmaceutical Formulation


Chemometrically Assisted RP-HPLC and Spectroscopic Method Development for Simultaneous Multi-Component Analysis of Ledipasvir and Sofosbuvir in Pure and Pharmaceutical Formulation


Roma N. Trivedi*1, Jinal N. Tandel1, Samir K. Shah2

1Department of Quality Assurance, Sardar Patel College of Pharmacy, Vidyanagar-Vadtal Road, Bakrol, (388315) Gujarat, India
2Department of Pharmacology, Sardar Patel College of Pharmacy, Vidyanagar-Vadtal Road, Bakrol, (388315) Gujarat, India


Journal of Pharmaceutical Research and Reviews

Hepatitis C virus (HCV) is an RNA virus that chronically infects about 71 million individuals worldwide [1]. Approximately 80% of acutely infected HCV patients progress to chronic infection, 20% of whom develop cirrhosis within 25 years, with 25 % of patients with cirrhosis developing hepatocellular carcinoma and/or decompensated liver disease. There are six major HCV genotypes with many subtypes based on genomic sequence heterogeneity. Since the discovery of HCV in 1989, strategies to cure the infection have evolved dramatically. A cure is defined as a sustained virologic response and consists of undetectable levels of plasma HCV RNA 12 or 24 weeks after completion of therapy. Among the people who have chronic HCV infection, approximately 60% have the genotype 1 strain of the virus. The treatment of patients infected with HCV genotype 1 is rapidly evolving. HCV therapy has been recently revolutionized by the development and approval of direct-acting antiviral agents (DAAs), borne out of the intense study of the viral life cycle and the elucidation of the crystal structure of several critical viral proteins [2,3].
Ledipasvir and Sofosbuvir in combination are directly acting antivirals attacking at the former stage of replication, reducing the disease leading to its chronicity. SOF is chemically known as (S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3hydroxy-4-methyl tetrahydrofuran-2-yl)methoxy)-(phenoxy) phosphorylamino) propanoate (Fig.1a). It has a molecular formula of C22H29FN3O9P and a molecular weight of 529.54. Sofosbuvir is white to off-white powder with a solubility of ≥ 2 mg/mL across the pH range of 2-7.7 at 37°C. The partition coefficient (log P) for Sofosbuvir is 1.62 and the pKa is 9.3. Sofosbuvir is a pangenotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication [4,5].


Keywords: RP-HPLC and Spectroscopic Method Development, Simultaneous Multi-Component Analysis, Ledipasvir and Sofosbuvir, Pure and Pharmaceutical Formulation

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How to cite this article:
Roma N. Trivedi, Jinal N. Tandel, Samir K. Shah. Chemometrically Assisted RP-HPLC and Spectroscopic Method Development for Simultaneous Multi-Component Analysis of Ledipasvir and Sofosbuvir in Pure and Pharmaceutical Formulation. Journal of Pharmaceutical Research and Reviews, 2018; 2:10.


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