RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF COBICISTAT AND ATAZANAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM
DOI:
https://doi.org/10.22270/ijmspr.v3i1.18Keywords:
RP-HPLC, Cobicistat, Atazanavir, ValidationAbstract
A stability indicating RP-HPLC method has been developed and subsequently validated for the simultaneous estimation of cobicistat and atazanavir in API and tablet dosage form. Optimized chromatographic condition were achived by Eclipse XBD-C18(250mm x 4.6mm, 5µ) column, mobile phase as a mixture of buffer (0.02M potassium dihydrogen phosphate, pH-2.5): acetonitril in the ratio of 40:60v/v with a flow rate of 1ml/min., UV detection was performed at 230nm and the sample temperature was maintained ambient which was injected manually. This developed method for simultaneous estimation of cobicistat and atazanavir is linear over a range of 60 – 180 ìg/ml and 120 -360 ìg/ml respectively. The validation parameters as per ICH guide lines show good precision having 0.054 and 0.083 %RSD for cobicistat and atazanavir which shows nice repeatability, limit of detection and limit of quantification for cobicistat and atazanavir was found to be 0.075 and 0.06 and 0.225 and 0.18 ìg/ml respectively. The developed method is easy to perform assay for indicating quality control determinations in bulk and formulated form with rapid, selective and stability indicating.
References
https://en.wikipedia.org/wiki/Cobicistat.
https://www.drugs.com/mtm/cobicistat.html.
https://en.wikipedia.org/wiki/atazanavir
https://www.drugs.com/cdi/atazanavir.html.
https://www.accessdata.fda.gov/drugsatfda_ docs/label/2015/206353s000lbl.pdf.
Eve-Irene Lepist Et al., Cobicistat Boosts the Intestinal Absorption of Transport Substrates, Including HIV Protease Inhibitors and GS-7340, In Vitr, Antimicrobial Agents Chemother., Vol 56(10), pg 5409-5413. oct 2012.
Kavitha K, Geetha Y, Hariprasad G, Venkatnarayana R and Subramanian R (Jan, 2013) “Development and Validation of Rp-hplc Analytical Method For Simultaneous Estimation of Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate And Its Pharmaceutical Dosage Forms”, Academic Journal Pharmacie Globale, [Online], Vol. 4 No. 1, P. 1.
Charushila H B and Shivanand N H (2013), Stability Indicating RP-HPLC Method for the Determination of Atazanavir Sulphate in Bulk and Dosage Form”, Drug Invention Today, Vol. 5, pp. 81-86.
Reddy B V, Jyothi G, Reddy B S, Raman N V, Reddy K S and Rambabu C (2013), Stability-indicating HPLC Method for the Determination of Darunavir Ethanolate”, J Chromatogr Sci., Vol. 51, pp. 471-476.
Tulsidas Mishra and Pranav S S (2014), “Validation of Simultaneous Quantitative Method of HIV Protease Inhibitors Atazanavir, Darunavir and Ritonavir in Human Plasma by UPLCMS/MS”, The Scientific World Journal, pp. 1-12.
Urooj Fatima, Mamatha T and Rajesh Goud Gajula (2014), “A Novel RP-HPLC Method Development and Validation of Cobicistat in Bulk Drug and Tablet Dosage Form”, Der. Pharmacia Sinica, Vol. 5, pp. 99-105
Sindu Priya D and Gowri Sankar D (2015), “Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Determination of Atazanavir and Cobicistat in Bulk and Pharmaceutical Formulation”, Am. J. Pharm. Tech. Res., Vol. 6, No. 1.
United States Pharmacopeia USP 34-NF 29, (2011).
ICH Guidelines on Validation of Analytical procedure: Text and Methodology Q 2 (R1), (2011)
Published
How to Cite
Issue
Section
Copyright (c) 2017 G Veerabhadram, CVS Subramanyam, Ravikumar Vejendla
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
.