TECHNO-ECONOMIC, MS COMPATIBLE HPLC METHOD DEVELOPMENT FOR THE ESTIMATION OF EMPAGLIFLOZIN IN BULK AS WELL AS PHARMACEUTICAL FORMULATION: APPLICATION IN ROUTINE ANALYSIS OF EMPAGLIFLOZIN IN MANUFACTURING INDUSTRIES

2021 ◽  
Vol 10 (12 (SPECIAL ISSUE)) ◽  
Author(s):  
Roshani Singh ◽  
Omray L K ◽  
Pushpendra Soni

In this article “new cost-effective RP-HPLC method development and validation for quantitative estimation of ivacaftor in the pharmaceutical formulation” developed. This study includes RP-HPLC Spectrophotometric method development, such as economical and simple HPLC method was optimized during development and validated accordingly in tablets of ivacaftor. The developed method may 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 the tablet dosage form. The present proposed method is capable of better separation of analyte and qualifies on the point of analytical validation 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 tablet formulations 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.


2012 ◽  
Vol 2 (2) ◽  
pp. 364-367 ◽  
Author(s):  
Saida Naik Dheeravath ◽  
◽  
Kasani Ramadevi ◽  
Zilla Saraswathi ◽  
Dheeravath Maniklal ◽  
...  

Author(s):  
G.M. Kadam ◽  
A.L. Puyad ◽  
T.M. Kalyankar

A new, economical, simple, accurate, and precise RP-HPLC method was developed for simultaneous assay and content uniformity determination of Sacubitril and Valsartan in bulk and pharmaceutical dosage form. The separation of Sacubitril and Valsartan was achieved within 6 minutes on Phenomenex Luna C18 250 mm x 4.6mm and 5µm Particle Size, column using Acetonitrile: Methanol: Water (30:55:15% v/v/v) as the mobile phase. Detection was carried out at 250 nm wavelength. The retention time of Sacubitril and Valsartan was found to be 2.361 and 3.304 min, respectively. The validation of the developed method was performed in terms of specificity, accuracy, precision, linearity, the limit of detection, the limit of quantification as mentioned in International Conference on Harmonization (ICH) guidelines. The method showed adequate sensitivity concerning linearity, accuracy, and precision over the range 12-36 μg/ml and 13-39 μg/ml for Sacubitril and Valsartan, respectively. The percentage recoveries obtained for Sacubitril and Valsartan were found to be in the range of 98.00 – 102.00 %. The proposed method is suitable for use in quality-control laboratories for quantitative analysis.


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