Abstract : Precision: The degree of agreement among individual test results when a method is applied to multiple samplings of a homogeneous sample. It is a measure of either the degree of reproducibility (agreement under different conditions) or of repeatability (agreement under same condition) of the method.
Linearity: The ability of a method to produce results that is directly or indirectly proportional to the conc. of the analyte in samples within a given range.
Range: The interval between upper and lower level of analyte (including those levels) that has been shown to be determined with precision, accuracy and linearity using the method as written.
Accuracy: The closeness of test results obtained by method to the true value. It is a measure of the exactness of the method.
Ruggedness: The ruggedness of an analytical method is the degree of reproducibility of test results obtained by analysis of the same samples under a variety of normal test conditions. Such as different laboratories, different analyst, different instruments, different lots of reagents different elapsed assay times, differently days at normal lab. Conditions etc. Intermediate precision is normally expressed as the lack of influence on test results of operational and environmental variables of the analytical method. Ultraviolet Visible spectrometric assay developed for the quantification of Ketoprofen was performed in methanol in the concentration of 10 mcgml. Single Point Standardization method was used for the quantitative analysis of drug. The drug obeys Lambert – Beer’s law in the concentration range of 5 mcgml. The absorbance maxima occur at 256 nm. The developed method was validated as per ICH norms. Single Point Standardization method involves simple calculations. The absorbance value at 256 nm was found to be around 0.291. The results obtained on the validation parameters of developed method meets the ICH requirements. It infers that the method was found to be simple, specific, precise, accurate, reproducible, reliable, linear and proportional (i.e.) it follows Lambert-Beer’s Law. The method was found to be rapid and economic. Hence it can be inferred that the above method was useful to be applied in routine laboratory analysis with a high degree of accuracy and precision.
Keywords: Ketoprofen, Analytical method development, Accuracy, Precision, Ruggedness, Robustness.