UPLC method development and validation for the simultaneous determination of Beclometasone and Formoterol in pharmaceutical dosage form

T Mallika, P Aparna,*, K Bhavyasri

Department of Chemistry, JNTUH College of Engineering, Kukatpally, Hyderabad, Telangana, India

Refer this article

T Mallika, P Aparna, K Bhavyasri , 2025 UPLC method development and validation for the simultaneous determination of Beclometasone and Formoterol in pharmaceutical dosage form. Journal of medical pharmaceutical and allied sciences, V 14 - I 4, Pages - 01 – 07. Doi: https://doi.org/10.55522/jmpas.V14I4.6914.

ABSTRACT

A new, simple, Accurate, precise UPLC method was developed for the simultaneous estimation of the Beclometasone and Formoterol in pharmaceutical dosage form. The chromatographic separation was carried out using an HSS C18 column (2.1 × 100 mm, 1.8 μm particle size), maintained at a temperature of 30°C. The mobile phase consisted of orthophosphoric acid and acetonitrile in a 57:43 volume ratio, delivered at a constant flow rate of 0.3 mL/min. Detection of both analytes was performed at 220 nm using a UV detector. Retention time of Beclometasone and Formoterol were found to be 0.607 min and 0.915 min. The developed method was validated as per ICH guidelines. All parameters met the acceptance criteria and this method can be applied for use in routine quality control, formulation analysis, and stability monitoring in pharmaceutical environments.

Keywords:

Beclometasone, Formoterol, UPLC method, Asthma, COPD, Quality Control, ICH guidelines.

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