Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF ATROPINE SULPHATE AND DIPHENOXYLATE HYDROCHLORIDE IN TABLET DOSAGE FORM BY RP-HPLC

Vasubabu Padarthi*, Chanduluru Hemanth Kumar and Amit Kumar

ABSTRACT

An advancement method devepment and validation for simultaneous assessment of ATROPINE SULPHATE (ATS) and DIPHENOXYLATE HYDROCHLORIDE (DPH) in merged tablet dosage form by RP-HPLC. The column used in determination was Zorbax C18 (250 X 4.6mm X 3.5ì), mobile phase comprising of ortho phosphoric acid buffer: methanol in the ratio of 70:30 v/v. the flow rate and injection volume were 1.2ml/min and 15 microlitre respectively. The retention time was about 3.635 minutes and 7.586 minutes for ATS and DPH of a total run time of 15 minutes, linearity of the method was linear over the range of 50-150 ìg/ml for DPH and ATS respectively with a correlation of 0.999 for simultaneous assessment for ATS and DPH thus the method was fast, simple, elegant and less time consuming method.

Keywords: Atropine Sulphate, Diphenoxylate HCl, RP-HPLC.