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Method Development and Validation for the Simultaneous Estimation of Bilastine and Montelukast in Bulk and Pharmaceutical Dosage Forms by Rp-hplc

Year: 2025

Type: article

Abstract: A robust, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Bilastine and Montelukast in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved using a C18 column (150 x 4.6 mm, 5 µm) with an optimized mobile phase and a flow rate of 1.0 mL/min. Detection was performed at 260 nm. The method was validated according to ICH guidelines, demonstrating excellent linearity (R² > 0.999), accuracy (98–102% recovery), and precision (%RSD < 2.0%). The developed method was also found to be robust and specific, ensuring no interference from excipients. The results confirm the method’s suitability for routine quality control analysis of Bilastine and Montelukast in pharmaceutical formulations.

Source: Journal of Translational Research in Life Sciences

DOI: 10.71223/kwa4hz09

Authors: Laddika Lakshmi Hari Sahitya, Dr. P. Uma Devi, Dr. P. V. MADHAVI LATHA

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

OpenAlex ID: W4408880550

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