HPLC Validation Methods in the Pharmaceutical Industry

Image

Pharmaceutica Analytica Acta is an internationally renowned peer-reviewed publication that publishes many types of science communication relating to pharmaceutical ingredients and medications. Students, interns, academicians, scientists, pharma industry professionals, as well as medical and clinical professionals dealing with identification, quantification, and structural elucidation of drug molecules, will find the archived database of the journal to be a useful source of detailed information. In addition to analytical techniques, formulation, product analysis and marketing, quality control, and quality assurance in pharmaceutical analysis are some of the topics covered by this publication. In the pharmaceutical sector, analytical techniques, such as chromatographic techniques, are frequently employed for the quantitative and qualitative examination of raw materials, drug ingredients, drug products, and chemicals in biological samples. Drugs that are chiral or achiral, process impurities, residual solvents, excipients like preservatives, degradation products, extractable and leachable materials from the container and closure or manufacturing process, pesticides in plant-based drug products, and metabolites are among the components that are monitored. Specificity is the ability of the analytical procedure to distinguish between the analytical and other components of the sample matrix. The analyte peak must be completely separated from other peaks coming from the sample matrix when utilising an HPLC method. By individually injecting solutions of the standard, sample, placebo, and blank into the chromatographic apparatus, specificity was evaluated. By dilution the stock standard solution with the mobile phase, different exact concentrations of potassium guaiacolsulfonate (0.127, 0.204, 0.254, 0.305, and 0.382 mg/mL) and sodium benzoate (0.238, 0.381, 0.476, 0.571, and 0.714 mg/mL), which correspond to 50%, 80%, 100%, 120%, and 150% of the target concentration, respectively, were obtained. This was done The signal-to-noise ratio for each analyte was assessed in order to ascertain the limits of detection (LOD) and limit of quantitation (LOQ) for each solution of potassium guaiacolsulfonate and sodium benzoate. By dilution the stock standard solution with the mobile phase, different exact concentrations of potassium guaiacolsulfonate (0.127, 0.204, 0.254, 0.305, and 0.382 mg/mL) and sodium benzoate (0.238, 0.381, 0.476, 0.571, and 0.714 mg/mL), which correspond to 50%, 80%, 100%, 120%, and 150% of the target concentration, respectively, were obtained. This was done the signal-to-noise ratio for each analyte was assessed in order to ascertain the limits of detection (LOD) and limit of quantitation (LOQ) for each solution of potassium guaiacolsulfonate and sodium benzoate. One way to test assay precision is to either prepare three samples in triplicate at three concentrations that cover the method's recommended range or take measurements from six samples at 100% concentration. There is a need for repeated analyses of the same sample. Intermediate precision is used to express variation within laboratories, such as different days, analysts, equipment, etc. The USP definition of roughness is the same as the phrase in question. The degree of intermediate precision should be created based on the circumstances under which the method will be used. The range of an analytical technique is the range between the analytic's higher and lower concentrations in the sample (which contains these concentrations), for which it has been established that the linearity, precision, and accuracy of the analytical method are sufficient.