Development and validation of the method for simultaneous determination of Benzydamine hydrochloride and methylparaben in dosage form by HPLC

Authors

DOI:

https://doi.org/10.15587/2519-4852.2020.206579

Keywords:

HPLC, Benzydamine hydrochloride, Methylparaben, method validation, simultaneous determination.

Abstract

The aim. The aim of the current work was to develop and validate HPLC method for simultaneous determination of Benzydamine hydrochloride (API) and methylparaben (preservative) in the dosage form containing Benzydamine hydrochloride as an active pharmaceutical ingredient.

Methods. The separation was performed on Grace Altima C18 column (250 mm * 4.6 mm, particle size 5 microns). The mobile phase consisted of 3.0 g of sodium perchlorate, 1 ml of trimethylamine and was adjusted to pH 3 with perchloric acid. The flow rate of mobile phase was 1 ml/min, detection wavelength was 320 nm for Benzydamine hydrochloride and 254 nm for Methylparaben.

Results. The method was validated according to ICH Q2 requirements and found to be robust, specific, linear in the range of 80–120 % for the analytes. The maximum RSD for each compound was less than 1.3 %. The accuracy of the method was within the acceptance criteria.

Conclusions. The method for simultaneous determination of Benzydamine hydrochloride and methylparaben was developed and validated according to the International Conference on Harmonization requirements. All validation parameters matched the acceptance criteria of the guideline.

The developed method can be applied in routine control in QC laboratories for simultaneous determination of Benzydamine hydrochloride and Methylparaben in Benzydamine dosage forms.

Author Biographies

Vasyl Chornyi, SC «Farmak» Kirilivska str., 63, Kyiv, Ukraine, 04080

Head of Laboratory

Liquid dosage forms R&D laboratory

Olga Chorna, Kharkiv Medical Academy of Postgraduate Education Amosova str., 58, Kharkiv, Ukraine, 61176

PhD, Assistant

Department of Clinical Biochemistry, Toxicology and Pharmacy

Victoriya Georgiyants, National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Doctor of Pharmaceutical Sciences, Professor, Head of Department

Department of Pharmaceutical Chemistry

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Published

2020-06-30

How to Cite

Chornyi, V., Chorna, O., & Georgiyants, V. (2020). Development and validation of the method for simultaneous determination of Benzydamine hydrochloride and methylparaben in dosage form by HPLC. ScienceRise: Pharmaceutical Science, (3 (25), 12–19. https://doi.org/10.15587/2519-4852.2020.206579

Issue

No. 3 (25) (2020)

Section

Pharmaceutical Science

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Copyright (c) 2020 Vasyl Chornyi, Olga Chorna, Victoriya Georgiyants

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