DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ANALYSING ANTIHYPERLIPIDEMIC AGENTS BY QBD APPROACH
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| Natura: | Recurso digital |
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2025
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| _version_ | 1866902152108048384 |
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| author | Nilakshi S. Punwatkar Tejashri B. Kadu Dr. Sachin J. Dighade |
| author_facet | Nilakshi S. Punwatkar Tejashri B. Kadu Dr. Sachin J. Dighade |
| contents | <p>A simple, specific, and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of niacin and lovastatin in bulk and tablet formulations. Chromatographic separation was achieved using a Solar C18 column (150 mm × 4.6 mm, 5 μm) with a mobile phase consisting of Methanol: Acetonitrile: 20 mM Ammonium Acetate Buffer (pH 5.5, adjusted with glacial acetic acid) in the ratio of 50:30:20 (v/v/v) at a flow rate of 1.2 mL/min. The retention times for niacin and lovastatin were found to be 2.2 min and 9.4 min, respectively. A Quality by Design (QbD) approach using a 2³ full factorial design was applied to optimize the mobile phase, with the optimized ratio being Methanol: Acetonitrile: Buffer at 45:40:15 (v/v/v). Detection was carried out at 225 nm using a UV detector. Calibration curves showed linearity in the range of 250-750 μg/mL for niacin and 10-30 μg/mL for lovastatin. The method was validated according to ICH and USP guidelines, showing acceptable results for accuracy, precision, linearity, and robustness. This method is suitable for routine analysis of niacin and lovastatin, both individually and in combination, in pharmaceutical tablet dosage forms.</p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_16886253 |
| institution | Zenodo |
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| publishDate | 2025 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ANALYSING ANTIHYPERLIPIDEMIC AGENTS BY QBD APPROACH Nilakshi S. Punwatkar Tejashri B. Kadu Dr. Sachin J. Dighade <p>A simple, specific, and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of niacin and lovastatin in bulk and tablet formulations. Chromatographic separation was achieved using a Solar C18 column (150 mm × 4.6 mm, 5 μm) with a mobile phase consisting of Methanol: Acetonitrile: 20 mM Ammonium Acetate Buffer (pH 5.5, adjusted with glacial acetic acid) in the ratio of 50:30:20 (v/v/v) at a flow rate of 1.2 mL/min. The retention times for niacin and lovastatin were found to be 2.2 min and 9.4 min, respectively. A Quality by Design (QbD) approach using a 2³ full factorial design was applied to optimize the mobile phase, with the optimized ratio being Methanol: Acetonitrile: Buffer at 45:40:15 (v/v/v). Detection was carried out at 225 nm using a UV detector. Calibration curves showed linearity in the range of 250-750 μg/mL for niacin and 10-30 μg/mL for lovastatin. The method was validated according to ICH and USP guidelines, showing acceptable results for accuracy, precision, linearity, and robustness. This method is suitable for routine analysis of niacin and lovastatin, both individually and in combination, in pharmaceutical tablet dosage forms.</p> |
| title | DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ANALYSING ANTIHYPERLIPIDEMIC AGENTS BY QBD APPROACH |
| url | https://doi.org/10.5281/zenodo.16886253 |