Author(s): Mohan Goud V, Tharun Goud G

Email(s): mohanvanga@yahoo.com

DOI: 10.5958/2231-5675.2020.00025.3   

Address: Mohan Goud V1*, Tharun Goud G2
1Department of Pharmaceutical Analysis, Joginpally B. R Pharmacy College, Yenkapally, Moinabad, R.R. Dist. Telangana.
2Department of Pharmacognosy, University College of Pharmaceutical Sciences, Palamuru University, Mahabubnagar, Telangana.
*Corresponding Author

Published In:   Volume - 10,      Issue - 3,     Year - 2020


ABSTRACT:
A simple, accurate and precise method was developed for the simultaneous estimation of the Glecaprevir [GPV] and Pibrentasvir [PNV] in Tablet dosage form by using HPLC. The chromatogram was run through Std. Zodiac column (150 x 4.6 mm, 5m) by using the mobile phase containing Buffer 0.1% OPA: Acetonitrile taken in the ratio 55:45. The flow rate maintained at 1 ml/min. and temperature set to 30°C. Optimized wavelength selected was 260 nm. The retention time of GPV and PNV were found to be 2.207 min and 3.263 min. %RSD of the GPV and PNV were and found to be 0.2 and 0.1 respectively. Average % Assay of marketed formulation of Glecaprevir and Pibrentasvir obtained was 99.56 and 99.25% respectively. LOD, LOQ values obtained from regression equations of GPV and PNV were 0.32, 0.97 and 0.04, 0.11 respectively. Regression equation of GPV was y = 23779x + 9673 and of PNV was y = 13508x + 2326. From the experimental results, the retention times were decreased and run time was decreased, so that the method developed was simple and economical that can be adopted in regular Quality control test in Industries.


Cite this article:
Mohan Goud V, Tharun Goud G. Stability indicating high performance liquid chromatography method development and validation for simultaneous estimation of Glecaprevir and Pibrentasvir in bulk and pharmaceutical dosage form. Asian J. Pharm. Ana. 2020; 10(3): 141-146. doi: 10.5958/2231-5675.2020.00025.3


REFERENCES:
1. Yvette N. Lamb. Glecaprevir/Pibrentasvir: First Global Approval Drugs. 2017; 77(16):1797-1804.
2. Lin C, Dutta S, Ding B, Wang T and Zadeikis N. 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.
3. Ng, Teresa I, Krishnan, Preethi, Pilot-Matias, Tami, Kati, Warren, Schnell, Gretja, Beyer, Jill, Reisch, Thomas, Lu, Liangjun, Dekhtyar, Tatyana, Irvin, Michelle, Tripathi, Rakesh, Maring, Clarence, Randolph, John T, Wagner, Rolf, Collins, Christine. "In Vitro Antiviral Activity and Resistance Profile of the Next-Generation Hepatitis C Virus NS5A Inhibitor Pibrentasvir". Antimicrobial Agents and Chemotherapy. 2017; 61 (5): e02558–16.
4. 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.
5. 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.
6. 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.
7. Saradhi NDVR, Dr. Rakesh Kumar Jat and Dr. Venkata Reddy M. A New Technical Method For Glecaprevir And Pibrentasvir In Combined Dosage Forms Using Non Polar HPLC. World Journal of Pharmaceutical and Medical Research. 2018; 4(12): 173-178.
8. China Babu D, Madhusudhana Chetty C and Mastanamma SK. 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. Pharm Methods, 2018; 9(2): 79-86.
9. Sreeram V, Venkateswarlu Ch. Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Glecaprevir and Pibrentasvir in Drug Product. J. Pharm. Sci. and Res. 2018; Vol. 10(11): 2757-2761.
10. Dr. Gampa Vijay Kumar, Sumanth Reddy D. RP-HPLC Method Development and Validation for Simultaneous Estimation of Glecaprevir and Pibrentasvir in Pharmaceutical Dosage Form. IAJPS 2018, 05 (12), 16827-16840.
11. Marakada Sridevia, Siva Rao T and Challa Gangu Naidu. Development and Alidation for the Simultaneous Estimation of Glecaprevir and Pibrentasavir in Drug Product by UPLC.  European Journal of Biomedical and Pharmaceutical sciences. 2018, Volume 5, Issue 4, 473-480.
12. ICH Harmonised Tripartite Guideline. Validation of analytical procedures, Text and methodology, Q1 R2. International Conference on Harmonization, 2005, 1-13. 
13.  ICH Harmonised Tripartite Guideline, Stability Testing of New Drug Substances and Products, Q1A (R2). International Conference on Harmonization, 2003, 1-18.

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DOI: 10.5958/2231–5675 

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