[On the "system repeatability" specified in the operating conditions for HPLC assay in JP monographs]

The system repeatability tests in the operating conditions for the HPLC assay by absolute calibration method are specified in 9 monographs in JP13 (Part 1). The reasonableness of the specified system repeatability, expressed in relative standard deviation(%), is discussed in consideration with the specified content and also the probability of Type 1 error(alpha). For simplification, it was assumed that the variance due to the analytical system(sigma s2) is equal to that due to other error sources(sigma e2). Based on the above considerations, it was concluded that the present specification of system repeatability(sigma s) in JP monographs is not always reasonable and some of them should be reexamined following to the described considerations in the text.