Development and validation of a single HPLC method for the determination of thirteen pharmaceuticals in bulk and tablet dosage form

The aim of this study was to develop and validate a high performance liquid chromatography (HPLC) method for the determination thirteen selected pharmaceutical compounds (metformin, amoxicillin, chloroquine, theophylline, trimethoprim, caffeine, norfloxacin, ciprofloxacin, acetylsalicylic acid, doxycycline hyclate, metronidazole, albendazole cloxacillin) in bulk tablet dosage form. Chromatographic separation using Kromasil C18 column, gradient elution with aqueous formic acid (0.1%), methanol acetonitrile, UV absorption wavelength 250 nm mobile phase flow rate 1 mL/min over 22 min run time optimized complete target compounds. validated results for: linearity, precision, sensitivity, accuracy, specificity, suitability robustness were obtained met ICH guidelines. Calibration curve correlation coefficients ranged from 0.9985-0.9998 percentage relative standard deviations repeated analysis below 5%, indicating acceptable precision. limits detection (LODs) quantification (LOQs) 0.020-0.27 µg/L 0.080-0.91 µg/L, respectively. accuracy yielded recoveries ranges 86.0-102% pure 90.9-106% is robust small or deliberate changes chromatographic parameters found be appropriate tablets pharmaceuticals.
 
 KEY WORDS: Pharmaceuticals, Bulk determination, Tablet dosage, High chromatography, Method development, guidelines
 Bull. Chem. Soc. Ethiop. 2021, 35(1), 17-31.
 DOI: https://dx.doi.org/10.4314/bcse.v35i1.2