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Currently a great number of generic drugs have been registered in Ukraine. The advantage of generic drugs is a relatively low cost compared to innovative medicines since creation and registration of generics require less research and, consequently, less material costs for development, research and market penetration of a new drug. Because of creation of the second edition of SPhU and inclusion of articles on the finished products, we have set ourselves the goal to analyze the validation characteristics of the quantitative chromatographic determination of nifedipine in tablets and to verify the analytical procedure. Linearity of the method was determined in the range of 80-120% of the nominal concentration. Linearity of the method has been confirmed within the whole range of concentrations studied (b = 1.0031, Sb = 0.0007816, a = -0.11, Sa = 0.07891, S0 = 0.03055, r = 1.0000). It has been proven that the method suggested is characterized by sufficient convergence and accuracy over the entire range of concentrations (ΔZ = 0.06, δ% = 0.2). The intermediate precision has been confirmed by the fact that the value of the relative confidence interval for five parallel measurements of one batch of the drug meets the acceptance criterion (Δz = 0.22%≤1.6%). Thus, according to the results of determining the validation characteristics of the methods for quantitative determination it has been substantiated and experimentally proven that this analytical procedure can be correctly reproduced, gives accurate results and is suitable for the analysis of nifedipine tablets. In the process of verification of the method for quantitative determination of nifedipine in tablets such validation characteristics of the chromatographic method as accuracy, linearity, precision, specificity and intermediate precision have been studied. The validation characteristics of the method do not exceed the critical value of error (1.6%) and are characterized by qualitative analytical indicators. This method can be correctly reproduced in the laboratory conditions.

Verification of HPLC for the quantitative determination method of nifedipine in tablets