Abstract
Tuberculosis (TB) remains a life-threatening infection, and it is well-known that effective TB treatment is associated with multiple drugs administered to infected patients on a daily basis. Terizidone (TZD) is an anti-TB drug used in the treatment of multi-drug resistant and extensively drug-resistant TB but presents with polyneuropathic adverse effects in some patients. To counteract these adverse effects, TZD is typically prescribed with pyridoxine (PDX), well known as Vitamin B6. As part of a pre-formulation study investigating the potential to co-formulate these two compounds, it became necessary to have a simple and reliable reversed-phase high-performance liquid chromatography (RP-HPLC) method. Optimal, simultaneous separation and detection of TZD and PDX were obtained using an isocratic mobile phase setup, consisting of ultrapure water and acetonitrile (30:70% v/v), with 1 mL glacial acetic acid added to the mobile phase mixture. A Discovery® C18, 150 × 4.6 mm, 5 μm column maintained at ambient temperature was utilized, with a detection wavelength of 260 nm. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), specificity, robustness, and solution stability. Validation proved this method to be acceptable and reliable for the simultaneous accurate detection and quantification of TZD and PDX.
Highlights
Tuberculosis (TB) is a communicable infectious disease that is caused by Mycobacterium tuberculosis, and it produces silent, latent infection and active disease
Pyridoxine hydrochloride (PDX), known as Vitamin B6, is a water-soluble compound involved in several enzymatic reactions in the human body
Accuracy The accuracy of this analytical method was investigated through recovery studies, which were performed by the spiking of a standard solution, resulting in five solutions at the following concentration levels: 50, 100, 200, 300, and 400 μg/mL for both TZD and PDX
Summary
Tuberculosis (TB) is a communicable infectious disease that is caused by Mycobacterium tuberculosis, and it produces silent, latent infection and active disease. Accuracy The accuracy of this analytical method was investigated through recovery studies, which were performed by the spiking of a standard solution, resulting in five solutions at the following concentration levels: 50, 100, 200, 300, and 400 μg/mL for both TZD and PDX. Reproducibility (inter-day precision) is based on variation, which may include the variation obtained on different days, associated with different analysts or equipment [14] The reproducibility of both TZD and PDX analyzed using this method was determined through a consecutive analysis across three days with solutions containing 200 μg/mL TDZ and PDX in combination. The LOD and LOQ for TZD and PDX were calculated based on the standard deviation of the response and the slope as recommended by the ICH guidelines on analytical method development and validation [14], using ANOVA statistical analysis and applying the following equations: LOD = 3.3σ/b (1). Where σ is the standard deviation of the response values across the concentration range used to determine linearity and range of the analytical method and b is the slope of the calibration curve
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