Research Paper on Enhancement and Validation of a Chromatographic Method for Isoniazid Quantification in Tuberculosis Patients’ Urine in Compliance with the European Medicines Agency Guidelines

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Title: Enhancement and Validation of a Chromatographic Method for Isoniazid Quantification in Tuberculosis Patients’ Urine in Compliance with the European Medicines Agency Guidelines

Abstract: A common drug used to treat tuberculosis is isoniazid. However, it exhibits high interpatient variability in metabolism kinetics and clinical effect, complicating medication prescription and endangering the efficacy of therapy. To determine the right dosage and frequency of intake for the drug to be suitable for therapeutic drug monitoring, the pharmacokinetics of the drug must therefore be clarified in a particular patient. This can be done through the non-invasive method of quantifying the drug in urine, which also makes it possible to infer the effects of prolonged exposure. The development of a micellar liquid chromatographic method to measure isoniazid in urine samples is described in the paper. The procedure was simplified by avoiding extraction steps, which also decreased the amount of hazardous organic solvents that were wasted. With a mobile phase containing 0.15 SDS, 12.5% 1-propanol (v/v)-Na2HPO4 0.01 M buffered at pH 7, running at 1 mL/min in isocratic mode through a C18 column with the detection wavelength at 265 nm, isoniazid was eluted in less than 5 minutes without interference from other urine compounds. Following the guidelines in the European Medicines Agency’s (EMA) Guidelines on Bioanalytical Method Validation, the method was validated for selectivity, calibration curve (r 2 = 0.9998 in the calibration range (0.03-10.0 g/mL), limit of detection and quantification (10 and 30 ng/mL, respectively), precision (16.0%), accuracy (0.9 to +8.5%), carry-over, matrix effect, and robustness. With good results, the developed method was used to measure isoniazid in urine samples from patients at an Indian hospital. The technique was discovered to be helpful for routine analysis to verify the concentration of isoniazid in these patients and could be used in its therapeutic monitoring.

Keywords: direct injection; drug; micellar; tuberculosis; urine; validation

Paper Quality: SCOPUS / Web of Science Level Research Paper

Subject: Antibiotics

Writer Experience: 20+ Years

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