Speaker
Description
A simple and reliable RP-HPLC-DAD method was developed and validated for the simultaneous determination of seventeen β-lactam and non-β-lactam active pharmaceutical ingredients (APIs) using a single chromatographic system. Separation was achieved on a Phenosphere C18 column (100 mm × 4.6 mm, 5 μm) employing tetraheptylammonium bromide (THAB) aqueous solution and acetonitrile as the mobile phase. Mobile Phase A and B consisted of THAB solution/acetonitrile ratios of 950:50 and 750:250 (v/v), respectively, with pH adjusted to 6.3 using phosphoric acid. Detection was performed at 230nm with a flow rate of 1.0 mL min⁻¹ and column temperature of 35 ± 2°C. The method was validated according to ICH guidelines for specificity, accuracy, recovery, linearity, limit of detection (LOD), and limit of quantification (LOQ). Excellent chromatographic performance was observed with satisfactory resolution, peak symmetry, and theoretical plate counts for all analytes. Linearity was established over concentration levels ranging from 50% to 250%, yielding correlation coefficients (R²) between 0.9972 and 0.9999. Relative standard deviation values were below 2.0%, while LOD and LOQ values were approximately 3 ppm and 10 ppm, respectively. The developed method provides a precise, accurate, and cost-effective approach for the simultaneous analysis of multiple APIs and is suitable for routine pharmaceutical quality control applications.
| Are you participating to the "AnaEE Environmental Rising Star Award "? | Yes |
|---|