Optimization And Validation of RP HPLC Method for The Quantification of Betaxolol Hydrochloride in Bulk Drug and Nanoformulation

The present study focuses on the optimization and validation of a simple, accurate, and precise Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method for the quantification of betaxolol hydrochloride in bulk drug and nanoformulations. The chromatographic separation was achieved using a C18 column with a suitable mobile phase, maintaining an optimal flow rate and detection wavelength. The method was validated as per ICH guidelines for parameters including linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantitation (LOQ). The method exhibited excellent linearity within the selected concentration range, with a correlation coefficient (R²) close to 1. Results indicated high recovery and low %RSD values, confirming the method's accuracy and precision. The developed RP-HPLC method is suitable for routine quality control and stability analysis of Betaxolol hydrochloride in both bulk drug and nanoformulation dosage form

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-06-30
DOI
https://doi.org/10.5281/zenodo.15771382
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

Optimization And Validation of RP HPLC Method for The Quantification of Betaxolol Hydrochloride in Bulk Drug and Nanoformulation

Zenodo (CERN European Organization for Nuclear Research)
Analytical Methods in Pharmaceuticals
article

Optimization And Validation of RP HPLC Method for The Quantification of Betaxolol Hydrochloride in Bulk Drug and Nanoformulation

article en

Abstract

The present study focuses on the optimization and validation of a simple, accurate, and precise Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method for the quantification of betaxolol hydrochloride in bulk drug and nanoformulations. The chromatographic separation was achieved using a C18 column with a suitable mobile phase, maintaining an optimal flow rate and detection wavelength. The method was validated as per ICH guidelines for parameters including linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantitation (LOQ). The method exhibited excellent linearity within the selected concentration range, with a correlation coefficient (R²) close to 1. Results indicated high recovery and low %RSD values, confirming the method's accuracy and precision. The developed RP-HPLC method is suitable for routine quality control and stability analysis of Betaxolol hydrochloride in both bulk drug and nanoformulation dosage form

Zenodo (CERN European Organization for Nuclear Research)
Openalex Percentile: Top 55%
Analytical Methods in Pharmaceuticals
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