scholarly journals New Cost-Effective RP-HPLC Method Development and Validation for Quantitative Estimation of Ivacaftor in Pharmaceutical Formulation

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.

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.


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