Abstract

SIMULTANEOUS ESTIMATION OF N-ACETYL CYSTEINE AND AMBROXOL HYDROCHLORIDE FROM TABLET DOSAGE FORM BY HPLC METHOD

Sunil V. Shanbhag* and Madhusudan T. Bachute

Abstract

A simple, precise, accurate and rapid RP-HPLC method has been developed for simultaneous estimation of N-Acetylcysteine and Ambroxol Hydrochloride in tablets dosage form. The method was carried out on C18 column (25cm x4.6 mm x 5μm) with a mobile phase consisting of Phosphate buffer solution and Methanol in 70:30 ratio. The flow rate was adjusted to 1.0 ml/minute and detection was carried out at 230 nm. The retention time obtained for NAcetylcysteine and Ambroxol Hydrochloride was 3.38 and 22.23 minutes respectively. The calibration areas were linear in the concentration range of 40-150 μg/ml for Ambroxol Hydrochloride and 40-150 μg/ml for N-Acetylcysteine. The developed method was svalidated in terms of accuracy, precision, linearity, limit of detection, limit of quantification, ruggedness and solution stability. The proposed method can be used for simultaneous estimation of these two drugs in tablet dosage form.

Keywords: Ambroxol Hydrochloride, N-Acetylcysteine, RP-HPLC, Validation, Tablet dosage form.