Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DAROLUTAMIDE IN TABLET DOSAGE FORM

Yogita Nawle*, Pratibha Daroi, Bhushan Sonawane, Aditi Bandre, Vijaya Kumar Munipalli, S. U. Warde and Raman Mohan Singh

Abstract

A simple, precise, accurate, high-performance thin-layer chromatography (HPTLC) method for determination of Darolutamide tablet dosage form has been developed and validated. Carbamazepine was used as Internal Standard (IS) in order to make the method more accurate and precise. Chromatographic separation of Darolutamide in tablet dosage fromulation and Carbamazepine was achieved on Silica gel 60 F254 HPTLC plates with mobile phase contain Tolune: Methanol: Ethyl Acetate: Acetic Acid in the proportion of (6:2:2:0.1 V/V/V/V). Darolutamide quantification was performed at 285 nm. Well-resolved bands were obtained with RF value 0.48. The method was validated for precision, accuracy, and specificity according to ICH guidelines. The calibration curve was found to be linear in the concentration range of 100-350 ng/band respectively. Correlation co-efficient by area was 0.9992. The method is selective and specific, with potential application in pharmaceutical analysis of these drugs in tablet dosage form.

Keywords: Darolutamide, Carbamazepine, High Performance Thin Layer Chromatography (HPTLC), Internal Standard (IS), Method development and Method Validation.