HPLC Determination of Sildenafil in Bulk and Tablet Dosage Form by Applying Green Analytical Chemistry

An eco-friendly reversed-phase High-performance liquid chromatography (RP-HPLC) method has been evolved and proven for the fast analysis of Sildenafil (SIL) in both bulk drug substances and commercial tablet formulations. The separation turned into the usage of a Lichrosphere RP C8 column (250 × four.0 mm, 5 μm particle length) as the stationary phase. The cellular segment consisted of a blend of ethyl acetate and ethanol (60:forty, v/v), selected as inexperienced solvents, with a waft charge of 1.0 mL/min and UV detection at 290 nm.The technique underwent complete validation, inclusive of assessments for linearity, selectivity, accuracy, precision, reproducibility, robustness, sensitivity, and specificity. The technique's suitability was confirmed by reading Sildenafil in each bulk drug and pill paperwork. It demonstrated incredible overall performance in phrases of selectivity, precision, reproducibility, accuracy, robustness, sensitivity, and specificity. For industrial pill formulations, the Sildenafil content change was found to be 101.25% and 98.67%, respectively. Additionally, the approach effectively separated the Sildenafil peak from its degradation products, confirming its capacity as a stability-indicating approach. These findings propose that the developed technique is good for the recurring analysis of Sildenafil in each bulk drug substance and finished pharmaceutical product.

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Publication Details

Journal
International Journal of Pharmaceutical Quality Assurance
Published
2024-12-25
DOI
https://doi.org/10.25258/ijpqa.15.4.36
Primary Topic
Pharmaceutical Quality and Counterfeiting
Type
article
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article

HPLC Determination of Sildenafil in Bulk and Tablet Dosage Form by Applying Green Analytical Chemistry

Shaileshkumar K. Koradia, Mayur Shirish Jain
International Journal of Pharmaceutical Quality Assurance
Pharmaceutical Quality and Counterfeiting
article

HPLC Determination of Sildenafil in Bulk and Tablet Dosage Form by Applying Green Analytical Chemistry

Shaileshkumar K. Koradia, Mayur Shirish Jain
article en

Abstract

An eco-friendly reversed-phase High-performance liquid chromatography (RP-HPLC) method has been evolved and proven for the fast analysis of Sildenafil (SIL) in both bulk drug substances and commercial tablet formulations. The separation turned into the usage of a Lichrosphere RP C8 column (250 × four.0 mm, 5 μm particle length) as the stationary phase. The cellular segment consisted of a blend of ethyl acetate and ethanol (60:forty, v/v), selected as inexperienced solvents, with a waft charge of 1.0 mL/min and UV detection at 290 nm.The technique underwent complete validation, inclusive of assessments for linearity, selectivity, accuracy, precision, reproducibility, robustness, sensitivity, and specificity. The technique's suitability was confirmed by reading Sildenafil in each bulk drug and pill paperwork. It demonstrated incredible overall performance in phrases of selectivity, precision, reproducibility, accuracy, robustness, sensitivity, and specificity. For industrial pill formulations, the Sildenafil content change was found to be 101.25% and 98.67%, respectively. Additionally, the approach effectively separated the Sildenafil peak from its degradation products, confirming its capacity as a stability-indicating approach. These findings propose that the developed technique is good for the recurring analysis of Sildenafil in each bulk drug substance and finished pharmaceutical product.

International Journal of Pharmaceutical Quality Assurance
Manubhai Patel Dental College and Hospital (IN)
Openalex Percentile: Top 59%
Pharmaceutical Quality and Counterfeiting
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