ANALYTICAL DETERMINATION OF STEROIDAL ADULTERANTS IN HOMEOPATHIC AND HERBAL FORMULATIONS BY LIQUID CHROMATOGRAPHY MASS CHROMATOGRAPHY (LCMS/MS)

Abhishek Dwivedi Ph.D.*, Savita Dwivedi, Shanu Dwivedi, Som Singh

ABSTRACT

A rapid and sensitive liquid chromatography–tandem mass spectrometry (LC-MS/MS) method was developed and validated for the determination of steroid residues in homeopathic and herbal drugs. Steroid adulteration in homeopathic and herbal formulations has raised serious safety concerns due to pharmacological effects and regulatory implications. Sample preparation involved solid-phase extraction (SPE) to isolate target analytes, followed by separation using reversed-phase LC with a C18 column. Detection was performed by electrospray ionization in positive ion mode. The method was validated for linearity, accuracy, precision, limit of detection (LOD) and limit of quantification (LOQ) according to ICH guidelines. The validated method was successfully applied to commercial homeopathic samples. This study demonstrates the applicability of LC-MS/MS for routine quality control of homeopathic and herbal formulations.

Keywords: Detection was performed by electrospray ionization in positive ion mode.