scholarly journals Development and Validation of Stability-indicating HPLC-DAD method for simultaneous determination of Emtricitabine, Rilpivirine, and Tenofovir Alafenamide in bulk and their Pharmaceutical dosage forms

2018 ◽  
Vol 11 (9) ◽  
pp. 329-339
Author(s):  
P. Saidulu ◽  
S.K. Mastanamma ◽  
P.V. Suresh ◽  
A.Prameela Rani
Keyword(s):  
Simultaneous Determination ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Tenofovir Alafenamide ◽  
Development And Validation

Development and validation of Stability-indicating RP-UPLC Method for the Simultaneous Determination of Ivacaftor, Tezacaftor and Elexacaftor in bulk and their Formulation

2021 ◽  
Vol 25 (12) ◽  
pp. 107-115
Author(s):  
V.V.S.S.N. Raju Sri Datla ◽  
Manikandan Ayyar
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
Drug Product ◽  
Dosage Forms ◽  
Combination Drug ◽  
Ultraviolet Detection ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Development And Validation

A simple reproducible stability indicating RP-UPLC method was developed for the simultaneous determination of Ivacaftor, Tezacaftor and Elexacaftor in their combined dosage forms using HSS C18, 1.8μm, 100mm x2.1 mm i.d. column. A mobile phase of phosphate buffer (10mM) pH-4.8 and acetonitrile in the ratio of 70: 30v/v mixture was used for separation and quantification of ivacaftor, tezacaftor and elexacaftor. The present drug analytes were run at a flow-rate of 0.3ml/ min at 30°C temperature. The injection volume was 2μL and with ultraviolet detection at 270nm. Under these conditions, elexacaftor, ivacaftor and tezacaftor were eluted at 0.72min, 1.4min and 1.9min respectively with a total run time shorter than 5min. The developed method was validated according to International Conference on Harmonization (ICH) guidelines. The developed RP-UPLC method was applied successfully for quality control assay of Ivacaftor, Tezacaftor and Elexacaftor in their combination drug product.

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