TL;DR
The developed RP-HPLC method effectively separates the drug from impurities and degradants, proving suitable for routine quality control and offering a robust, precise, and regulatory-compliant analytical tool for ensuring the quality of apatinib in both bulk and formulated products.
Objective: This study focused on designing and validating a reliable and efficient Quality by Design assisted RP-HPLC analytical procedure for efavirenz in bulk and tablet dosage form. Methods: The significant analytical variables (CMPs) were optimized by using Central Composite Design, analytical variables; including...
A stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative estimation of Tafamidis in bulk drug and pharmaceutical dosage forms. Chromatographic separation was achieved using a Phenomenex Gemini ODS C18 column (250 × 4.6 mm, 5 µm) with...
The AQbD-based RP-HPLC method is rapid, accurate, economical, and highly robust, making it suitable for routine quality control, stability testing, and regulatory applications in ketoconazole analysis.
An AQbD-based approach was employed to develop and validate a reliable, stability-indicating RP-HPLC method for quantifying sotagliflozin in API and tablet dosage forms, demonstrating good linearity, precision, accuracy, robustness, and sensitivity with low LOD and LOQ values.
A simple, rapid, sensitive, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination of promethazine hydrochloride (HCl) in pharmaceutical formulations. Chromatographic separation was achieved using a SunFire® C18 colum...
Nafithromycin is a novel ketolide antibiotic approved for the treatment of community-acquired bacterial pneumonia (CABP). The present study describes the development and validation of UV spectrophotometric and reverse-phase high-performance liquid chromatographic (RP-HPLC) methods for the quantitative determination of...
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