Optimization and Validation of an RP-HPLC Technique for the Concurrent Quantification of Sumatriptan and Naproxen in Raw Materials and Tablet Dosage Forms

This study focuses on the development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP- HPLC) method for the simultaneous quantification of Sumatriptan (SUT) and Naproxen (NAP) in both raw materials and tablet formulations. The method validation was carried out in accordance with established guidelines, assessing critical parameters such as linearity, precision, accuracy, and recovery to ensure its suitability for pharmaceutical analysis. The method demonstrated excellent linearity over a concentration range of 5-70 μg/mL for both SUT and NAP, with correlation coefficients (R²) of 0.9992 for Sumatriptan and 0.9994 for Naproxen. Recovery studies showed that the method is highly accurate, with average recovery rates of 99.36% for Sumatriptan and 99.47% for Naproxen. In the analysis of commercial tablet formulations, the method consistently produced precise and reproducible results. The retention times for Sumatriptan and Naproxen were recorded at 4.918 minutes and 3.256 minutes, respectively. Furthermore, the method exhibited strong selectivity, with a resolution factor (Rs) of 2.05 between the two compounds, indicating effective separation.

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Publication Details

Journal
International Journal of Pharmaceutical Quality Assurance
Published
2024-12-25
DOI
https://doi.org/10.25258/ijpqa.15.4.37
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

Optimization and Validation of an RP-HPLC Technique for the Concurrent Quantification of Sumatriptan and Naproxen in Raw Materials and Tablet Dosage Forms

A. U. Tatiya, Jayshri S. Borse
International Journal of Pharmaceutical Quality Assurance
Analytical Methods in Pharmaceuticals
article

Optimization and Validation of an RP-HPLC Technique for the Concurrent Quantification of Sumatriptan and Naproxen in Raw Materials and Tablet Dosage Forms

A. U. Tatiya, Jayshri S. Borse
article en

Abstract

This study focuses on the development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP- HPLC) method for the simultaneous quantification of Sumatriptan (SUT) and Naproxen (NAP) in both raw materials and tablet formulations. The method validation was carried out in accordance with established guidelines, assessing critical parameters such as linearity, precision, accuracy, and recovery to ensure its suitability for pharmaceutical analysis. The method demonstrated excellent linearity over a concentration range of 5-70 μg/mL for both SUT and NAP, with correlation coefficients (R²) of 0.9992 for Sumatriptan and 0.9994 for Naproxen. Recovery studies showed that the method is highly accurate, with average recovery rates of 99.36% for Sumatriptan and 99.47% for Naproxen. In the analysis of commercial tablet formulations, the method consistently produced precise and reproducible results. The retention times for Sumatriptan and Naproxen were recorded at 4.918 minutes and 3.256 minutes, respectively. Furthermore, the method exhibited strong selectivity, with a resolution factor (Rs) of 2.05 between the two compounds, indicating effective separation.

International Journal of Pharmaceutical Quality Assurance
Openalex Percentile: Top 72%
Analytical Methods in Pharmaceuticals
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