Quantification of ethinyl estradiol, levonorgestrel and ferrous fumarate from bulk drugs and tablet formulation using a validated HPTLC method

Abstract

Objective: This research paper proposes a new HPTLC method that is quick, accurate and precise for estimating ethinyl estradiol, levonorgestrel and ferrous fumarate. Materials and Methods: Quantification was performed on silica gel precoated aluminum plates as the stationary phase. As the three drugs did not resolved in one mobile phase, different mobile phases were selected for ethinyl estradiol and levonorgestrel i.e. chloroform: methanol in the ratio of 9.9: 0.1 v/v and for ferrous fumarate i.e. formic acid: dichloromethane: butanol: heptane in the ratio of 1.2: 1.6: 3.2: 4.4 v/v/v/v. Result: Wavelength for densitometric evaluation was 275 nm for ethinyl estradiol and levonorgestrel and 212 nm for ferrous fumarate. Ethinyl estradiol and levonorgestrel were acceptably resolved having a RF values of 0.16 ± 0.02 and 0.24 ± 0.02. Ferrous fumarate had a RF value of 0.74 ± 0.02. Conclusion: All the validation parameters were performed and results were found to be within the acceptable limit prescribe by ICH.