Research Journal of Pharmaceutical Dosage Forms and Technology
  • Year: 2021
  • Volume: 13
  • Issue: 1

Quantitative estimation of salbutamol sulphate in tablets using brady’s reagent by colorimetric method and validation of developed method

Department of Pharmaceutical Analysis, Centre for Pharmaceutical Sciences, Institute of Science and Technology, Jawaharlal Nehru Technological University, Hyderabad, Telangana - 500085, India

*Corresponding Author E-mail: sanaksm1996@gmail.com

Online published on 4 May, 2021.

Abstract

Salbutamol sulphate is a substantially used anti-asthmatic drug. Aim of this study was to develop a simple and cost-effective spectrophotometric method. The method developed for estimation of Salbutamol sulphate in tablet dosage form is a visible spectrophotometric method using Brady’s reagent. Brady’s reagent is used for qualitative and quantitative analysis of drug compounds containing carbonyl moieities (aldehydes and ketone) as functional group. Brady’s reagent reacts with carbonyl group and it undergoes nucleophilic addition-elimination reaction, a type of condensation reaction, this results in the formation of colored hydrazones. As Salbutamol sulphate contains aromatic carbonyl group (phenol) as functional group, hence Brady’s reagent is used for quantitative estimation of Salbutamol sulphate in tablet dosage form. By this developed assay developed using this reagent, percent label claim results were found to be within limits as per pharmacopoeia limits. The method developed was subjected to validation parameters as per ICH guidelines. The developed method obeyed Beer’s Lambert’s law. Linearity was found to be passed in concentration range of 10 to 50μg/mL. Based on validation results it was concluded that the developed method for the assay of Salbutamol sulphate in tablets was simple, accurate, linear, precise, robust and rugged. Hence the developed method can be applied in routine analysis for the assay of Salbutamol sulphate tablets. This method is simple and superior over other costly and sophisticated analytical procedures.

Keywords

Salbutamol sulphate, Anti-asthmatic, Brady’s reagent, Carbonyl, Condensation reaction, Hydrazones, Pharmacopeial limits, ICH