Simultaneous Chromatographic Analysis of Simeprevir and Sofosbuvir in Combined Formulation
DOI:
https://doi.org/10.52783/jns.v14.3626Keywords:
Simeprevir, sofosbuvir, RP-HPLC, method development, validation, stability studiesAbstract
New RP-HPLC method have been developed for simultaneous analysis of simeprevir and sofosbuvir in pharmaceutical formulation and applied to stability studies of drugs. The analytes were quickly eluted using a phosphate buffer at pH 3.50 and acetonitrile in a 25:75 %v/v ratio on a Hypersil BDS C18 column measuring 150 x 4.6 mm with a particle size of 5 µm. The detection was facilitated using a PDA detector at a wavelength of 253 nm. The analytes went through chromatography at a steady flow rate of 1 mL/min. Simeprevir and sofosbuvir were eluted at 2.1 min. and 5.3 min., respectively, demonstrating good resolution. The method was validated in accordance with ICH guidelines. The linearity range of simeprevir was determined to be 25 - 75 µg/mL, while for sofosbuvir, it was found to be 10 - 30 µg/mL. The % RSD values (< 2) in precision studies indicate the method's reproducibility. The percentage recoveries were 100.1% for simeprevir and 99.36% for sofosbuvir, both of which were found to be within the acceptable limits. The validated method was effectively utilized for the assay of formulation and stability studies of drugs under various stress conditions..
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Izquierdo L, Helle F, François C, Castelain S, Duverlie G, Brochot E. Simeprevir for the treatment of hepatitis C virus infection. Pharmacogenomics and personalized medicine. 2014:241-9.
Schinazi RF, Shi J, Whitaker T. Sofosbuvir (Sovaldi): The First‐in‐Class HCV NS5B Nucleotide Polymerase Inhibitor. Innovative drug synthesis. 2015:61-80.
McQuaid T, Savini C, Seyedkazemi S. Sofosbuvir, a significant paradigm change in HCV treatment. Journal of clinical and translational hepatology. 2015 Mar 15;3(1):27.
Sanford M. Simeprevir: a review of its use in patients with chronic hepatitis C virus infection. Drugs. 2015; 75(2):183-96.
Sclair SN, Hernandez MD, Vance E, Gilinski D, Youtseff H, Toro M, Antoine M, Jeffers LJ, Peyton A. Sofosbuvir and simeprevir combination therapy for HCV genotype 1 infection: Results of a single-center VA experience. Gastroenterology & Hepatology. 2016; 12(8):490.
Srinidhi M, Basha MM, Kumar VR, Kumar JR. Stability indicating RP-HPLC method development and validation for the estimation of sumatriptan in bulk and pharmaceutical dosage form. Journal of Applied Pharmaceutical Science. 2016; 6(6):020-5.
Swapna B, Kiran G, Vasudha B, Kumar JR. Stability indicating RP-HPLC method for simultaneous estimation of betamethasone dipropionate and calcipotriene in bulk and pharmaceutical dosage form. Biointerface Research in Applied Chemistry. 2018; 8(1):3089-94.
Akula G, Sapavatu SN, Jadi RK, Battineni JK, Boggula N. Analytical method development and validation for the estimation of tramadol in bulk and its formulations by UV-spectroscopy. Journal of Advanced Scientific Research. 2021; 12(02):77-83.
Žuvela P, Skoczylas M, Jay Liu J, Ba̧czek T, Kaliszan R, Wong MW, Buszewski B. Column characterization and selection systems in reversed-phase high-performance liquid chromatography. Chemical reviews. 2019; 119(6):3674-729.
Ezzeldin E, Abo-Talib NF, Tammam MH, Asiri YA, Amr AE, Almehizia AA. Validated reversed-phase liquid chromatographic method with gradient elution for simultaneous determination of the antiviral agents: sofosbuvir, ledipasvir, daclatasvir, and simeprevir in their dosage forms. Molecules. 2020; 25(20):4611.
Derayea SM, Abu-Hassan AA, Hamad AA, Eltoukhi WE, Hamad AE, Mohammed BS. Mathematical processing of absorption as green smart spectrophotometric methods for concurrent assay of hepatitis C antiviral drugs, Sofosbuvir and Simeprevir: application to combined pharmaceutical dosage forms and evaluation of the method greenness. BMC chemistry. 2023; 17(1):75.
Sharaff CS, Renukuntla P, Peddapalli H, Kuchukuntla M, Bakshi V, Jadi RK. Formulation, development, and characterization of loratadine emulgel. Journal of Applied Pharmaceutical Research. 2024; 12(2):42-50.
Jadi RK, Tatikonda A, Reedy PR, Venisetty RK. Design and characterization of pregabalin swellable core osmotic pumps. Int J Pharm Res Alli. 2016; 5:8-15.
Togaru V, Venisetty RK, Bakshi V, Jadi RK. Formulation Development and In Vitro Evaluation of Propranolol Hydrochloride Extended Release Matrix Tablets. Emergent Life Sciences Research. 2017; 3:38-47.
Guideline IH. Validation of analytical procedures Q2 (R2). ICH: Geneva, Switzerland. 2022.
Borman P, Elder D. Q2 (R1) validation of analytical procedures: text and methodology. ICH quality guidelines: an implementation guide. 2017:127-66.
Haque MA, Bakshi V, Boggula N. Analytical method development and validation of amlodipine in human plasma using liquid chromatography-mass spectrometry/mass spectrometry. Asian J Pharm Clin Res. 2018; 11(7):393-7.
Chettupalli AK, Kunduru V, Boggula N, Bakshi V. Development and validation of capecitabine tablet (pharmaceutical dosage form) by using RP-HPLC method. INDO American Journal of Pharmaceutical Sciences. 2017; 4(3):550-7.
Dandamudi SP, Battineni JK, Bakshi V, Peddapalli H, Boggula N. Validated RP-HPLC method for estimation of daclatasvir in tablet dosage form. Int J Adv Res Dev. 2018; 3(2):1170-4.
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