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What are the validation parameters for related substance by hplc analysis?
The validation parameters for related substances analysis by HPLC typically include specificity, linearity, accuracy, precision, detection limit, quantification limit, and robustness. Specificity ensures the method can differentiate between the analyte and impurities, while linearity confirms a linear relationship between concentration and response. Accuracy and precision assess the closeness of results to the true value and the method's repeatability. Detection and quantification limits determine the lowest concentration that can be reliably detected and quantified. Robustness evaluates the method's ability to remain unaffected by small variations in parameters.
Which is the current guideline for method validation?
ICH
What is A-BUFFER method?
an anti-aliased hidden surface method
What are the guidelines for method development of hplc according to ich?
the same guidelines for method validation
How buffer concentration effects on retention time in hplc method?
Buffer concentration can affect retention time in HPLC by influencing the pH of the mobile phase, which can in turn impact interactions between the analyte and stationary phase. Higher buffer concentrations can alter the ionization state of the analyte, leading to changes in its retention time. Additionally, buffer concentrations can also affect peak shape and resolution in the chromatogram.
The criterion-related validation method is generally preferred to other validation approaches because a. it is based on empirical data b. it tends to be less expensive c. it lacks generalizaiton d.?
A
Method validation was done in one column now the column has been changed for sample analysis weatherwe need to perform method validation once again or not?
you need equivalency study only by prepare 6 sample in the tow column (they should be same result)
What is a validation study?
USP definition: "Validation of an analytical method is the process that establishes, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical applications."
What is the procedure for analytical method development and validation process for tenofovir tablets?
once check in indian pharmacopia
Types of validation?
The type of validation used here is calculation validation. It involves using a known measurement (the thickness of a single sheet of paper) and multiplying it by the number of sheets to determine the total thickness. This method is based on the assumption that each sheet of paper has a uniform thickness, which is generally true for standard office paper.
Linearity is how much important in method validation?
its important for recover the calculation equation and for improve linearity equation (pears low )
What is difference between specificity and selectivity in hplc method validation?
Specificity refers to the ability of an analytical method to accurately measure the analyte of interest in the presence of potential interfering substances. Selectivity, on the other hand, refers to the ability of the method to only detect the analyte of interest while ignoring any other components present in the sample. Both are important parameters in HPLC method validation to ensure accurate and reliable results.
