European Journal of Biomedical and Pharmaceutical Sciences

STABILITY INDICATING HPLC DEPENDENT METHOD FOR QUALITY CONTROL QUANTIFICATION OF ETHINYLOESTRADIOL AND DIGENOEST IN COMBINATION FORMULATIONS

Y. Pavani, K. Anil Kumar, S. V. M. Vardhan and M. Subbarao*

ABSTRACT

Objective: An HPLC DNGT/EETL assay technique has been established for the assessment of DNGT and EETL in combination formulations. The Cosmicsin column (150 mm × 4.5 mm; 4.5 µ size) operating at room temperature and acetonitrile/phosphate buffer (0.1 M, pH 4.2, KH2PO4) with ratio of 45/55 v/v as mobile phase was used for DNGT and EETL separation and analysis. The flow rate about 1.0ml/min and the detection wavelength at 242 nm was employed. The EETL and DNGT were eluted at 1.760 and 2.309 min, respectively. With an R2 > 0.9999, a straight line relationship was found for the concentration ranges of 15 to 45 µg/ml (EETL) and 100 to 300 µg/ml (DNGT). The sensitivity could be seen using LOQ, which had values of 0.277 µg/ml (EETL) and 0.344 µg/ml (DNGT). The RSD <2% and recovery rates ranging from 99.77% to 101.10, respectively, demonstrated the accuracy and precision The stabilities of DNGT and EETL were tested under scenarios of basic, acidic, oxidative, photolytic and thermal stress. The procedure for DNGT and EETL analysis were verified in compliance with Q2R1 ICH guidelines. The suggested HPLC DNGT/EETL test procedure proved appropriate for the assessment of DNGT and EETL simultaneously during quality control and stability investigations.

Keywords: Acne, Ethinylestradiol, Dienogest, Stability indicating, Quality control.