Quantification of Drospirenone and Ethinyl Estradiol Related Impurities in a Combined Pharmaceutical Dosage Form by Chromatography Method with QbD Robustness Study.

Srinivasa Reddy Chinta Vaishnavi Chintala Vishnu Nandimalla Rajyalakshmi Ch Sasikiran Goud Ediga Leela Prasad Kowtharapu Naresh Kumar Katari

Published in: Journal of AOAC International (2023)

A gradient, accurate, precise, and stability-indicating reverse phase HPLC method has been developed and validated to determine drospirenone, ethinyl estradiol, and its nine related impurities in tablet formulation. A Quality by Design technique is used to establish a robustness study.

Keyphrases

mass spectrometry
ms ms
drug delivery
high resolution
tandem mass spectrometry
estrogen receptor
quality improvement
solid phase extraction