Open AccessNew Cost-Effective RP-HPLC Method Development and Validation for Quantitative Estimation of Ivacaftor in Pharmaceutical Formulation
Author(s) -
Ranjeet Kumar Singh,
L. K. Omray,
Pushpendra Soni
Publication year - 2021
Publication title -
international journal of pharmaceutical sciences review and research
Language(s) - English
Resource type - Journals
ISSN - 0976-044X
DOI - 10.47583/ijpsrr.2021.v71i01.006
Subject(s) - ivacaftor , dosage form , computer science , pharmaceutical formulation , analyte , reproducibility , robustness (evolution) , chromatography , chemistry , biochemistry , cystic fibrosis transmembrane conductance regulator , gene
In this article “new cost-effective RP-HPLC method development and validation for quantitative estimation of ivacaftor in thepharmaceutical formulation” developed. This study includes RP-HPLC Spectrophotometric method development, such as economicaland simple HPLC method was optimized during development and validated accordingly in tablets of ivacaftor. The developed methodmay utilize for the analysis of ivacaftor at the laboratory level. The result shows that developed methods are cost-effective, rapid(Short retention time), simple, accurate (the value and %RSD between 2-5), precise, and can be used for the intended purpose on thetablet dosage form. The present proposed method is capable of better separation of analyte and qualifies on the point of analyticalvalidation such as linearity, specificity, accuracy, precision, robustness, LOD, and LOQ on a marketed formulation. The simplicity,rapidity, and reproducibility of the developed method qualify the objective of the research. Results of analysis of the ivacaftor tabletformulations are arranged in the experimental, result, and discussion section. The portion of ivacaftor found in terms of quantity was between 98-102% and also within USP 29 chapter (541) acceptance criteria.