Research Journal of Pharmacy and Technology

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A New Stability- Indicating RP-HPLC- Pda Method for Simultaneous Estimation of Glecaprevir and Pibrentasvir in Tablet Dosage Form


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1 Department of Chemistry, Sri Krishnadevaraya University, Ananthapuramu-515003 A.P, India
     

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A simple, accurate, precise method was developed for the simultaneous estimation of the Glecaprevir and Pibrentasvir in tablet dosage form. Chromatogram was run through Std Zodiac 150 x 4.6 mm, 5. Mobile phase containing buffer 0.1% OPA: Acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.1% OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 260 nm. Retention time of Glecaprevir and Pibrentasvir were found to be 2.207 min and 3.263 min. %RSD of the Glecaprevir and Pibrentasvir were and found to be 0.4 and 0.3 respectively. %Recovery was obtained as 98.90% and 99.61% for Glecaprevir and Pibrentasvir respectively. LOD, LOQ values obtained from regression equations of Glecaprevir and Pibrentasvir were 0.32, 0.97 and 0.04, 0.11 respectively. Regression equation of Glecaprevir is y= 23713.x + 11307, y = 13524x +2221 of Pibrentasvir. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular quality control test in industries.

Keywords

Glecaprevir, Pibrentasvir, RP-HPLC Method Development, Validation.
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  • Fathi H, Clark A, Hill NR, Dusheiko G. Effectiveness of current and future regimens for treating genotype 3 hepatitis C virus infection: a large-scale systematic review. BMC Infect Dis. 2017; 17 (1):722.

  • Hemalatha K, Kistayya C, Nizamuddhin ND, Dastagiramma D. Simultaneous Estimation of New Analytical Method Development and Validation of Glecaprevir and Pibrentasvir by High performance Liquid chromatography. Innovat International Journal of Medical and Pharmaceutical Sciences. 2018;3(1):5-8.

  • Poordad F, Felizarta F, Asatryan A, Sulkowski MS, Reindollar RW.Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology. 2017;66(2):389-97.

  • Shethi PD. HPLC- Quantitative analysis of pharmaceutical formulations. 1st Ed. New Delhi: CBS Publishers & Distributors; 2001: 8-10, 101-103.

  • Teresa I, Rakesh Tripathi Ng , Reisch T, Liangjun Lu, Middleton T, et al. In vitro Antiviral Activity and Resistance Profile of the Next-Generation Hepatitis C Virus NS3/4A Protease Inhibitor Glecaprevir. Antimicrobial Agents and Chemotherapy. 2017;62(1):1-50.

  • Krishnan P, Schnell G, Tripathi R, Beyer J, Reisch T, et al. Integrated Resistance Analysis of CERTAIN-1 and CERTAIN-2 Studies in Hepatitis C Virus-Infected Patients Receiving Glecaprevir and Pibrentasvir in Japan. Antimicrobial Agents and Chemotherapy. 2018; 62(2):1-16.

  • Yvette N. Lamb. Glecaprevir/Pibrentasvir: First Global Approval Drugs. 2017; 77(16):1797-1804. 6. Lin C, Dutta S, Ding B, Wang T, Zadeikis N, et al. Pharmacokinetics, Safety, and Tolerability of Glecaprevir and Pibrentasvir in Healthy White, Chinese, and Japanese Adult Subjects. The Journal of Clinical Pharmacology. 2017;57(12):1616-24.

  • Kasture AV, Mahadik KR, Wadodkar SG, More HN. Pharmaceutical Analysis: Vol-II. 8th Ed. Pune: Nirali Prakashan; 2002: 48-57.

  • Sridevi M, T, Gangu Naidu C. European Journal of Biomedical and Pharmaceutical sciences. Development And Validation For The Simultaneous Estimation Of Glecaprevir And Pibrentasavir In Drug Product By Uplc. 2018; 5(4): 473-480.

  • Chinna babu D, Madhu sudhana chetty C, Mastanamma SK. Pharm Methods. A New Force Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Pibrentasvir and Glecaprevir in Bulk and its Tablet Dosage Form 2018; 9(2): 79-86.

  • Hemalatha K , Kistayya C, Nizamuddhin ND, Dastiagiriamma D.Simultaneous estimation of new analytical method development and validation of glecaprevir and pibrentasvir by high performance liquid chromatography. innovat international journal of medical and pharmaceutical sciences. 2018; 3(s1): 5-8.

  • International Conference on Harmonization (ICH) Q2 (R1): Validation of Analytical Procedures: Test and Methodology, Geneva, Switzerland. 2005.

  • Validation of Analytical Procedures: Methodology (Q2B), ICH Harmonized Tripartite Guidelines, Geneva, 1996.

  • ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, 2003.

  • ICH guidelines for impurities in new drug substances Text and methodology Q3A (R2), International Conference on Harmonization, 2006.


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  • A New Stability- Indicating RP-HPLC- Pda Method for Simultaneous Estimation of Glecaprevir and Pibrentasvir in Tablet Dosage Form

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Authors

Yeragodala Narendra Reddy
Department of Chemistry, Sri Krishnadevaraya University, Ananthapuramu-515003 A.P, India
Jadi Sreeramulu
Department of Chemistry, Sri Krishnadevaraya University, Ananthapuramu-515003 A.P, India
B. Balaswami
Department of Chemistry, Sri Krishnadevaraya University, Ananthapuramu-515003 A.P, India

Abstract


A simple, accurate, precise method was developed for the simultaneous estimation of the Glecaprevir and Pibrentasvir in tablet dosage form. Chromatogram was run through Std Zodiac 150 x 4.6 mm, 5. Mobile phase containing buffer 0.1% OPA: Acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.1% OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 260 nm. Retention time of Glecaprevir and Pibrentasvir were found to be 2.207 min and 3.263 min. %RSD of the Glecaprevir and Pibrentasvir were and found to be 0.4 and 0.3 respectively. %Recovery was obtained as 98.90% and 99.61% for Glecaprevir and Pibrentasvir respectively. LOD, LOQ values obtained from regression equations of Glecaprevir and Pibrentasvir were 0.32, 0.97 and 0.04, 0.11 respectively. Regression equation of Glecaprevir is y= 23713.x + 11307, y = 13524x +2221 of Pibrentasvir. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular quality control test in industries.

Keywords


Glecaprevir, Pibrentasvir, RP-HPLC Method Development, Validation.

References