Abstract

METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL AND HYOSCINE BUTYLBROMIDE IN TABLET DOSAGE FORM

S. S. Rajendran, N. Santhi, S. Suresh Kumar and R. Ajila*

ABSTRACT

In the present investigation, a simple and accurate reverse-phase high performance liquid chromatography method has been developed for simultaneous estimation of Paracetamol (PAR) and Hyoscine Butylbromide (HBB) in tablet dosage form by Isocratic elution. The chromatographic separation was performed on a Nucleodur, C 18, 250 x 4.6 mm column. The mobile phase consists of Buffer: Methanol (70: 30, pH adjusted with potassium dihydrogen orthophosphate), maintaining the flow rate at 1.0 mL/minute. The quantification was achieved with UV detection at 210nm. The retention time acquired for PAR was 3.94 and HBB was 10.02 min in a continuous run up to 20 min. The detector response was found to be linear in the concentration range of 10-50 mcg/ml for PAR and 0.2 -1.0 mcg/ml for HBB. The developed method is simple, accurate, precise, linear, specific and robust. This method may be recommended for the routine analysis in combined dosage forms and can be used for wash analysis. According to ICH guidelines the developed method was validated. The proposed method can be used for estimation of these drugs in combined pharmaceutical dosage forms.

Keywords: Paracetamol and Hyoscine Butylbromide, RP-HPLC, Development, Validation.