TAILIEUCHUNG - Wide Spectra of Quality Control Part 5

Tham khảo tài liệu 'wide spectra of quality control part 5', kỹ thuật - công nghệ, cơ khí - chế tạo máy phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | 110 Wide Spectra of Quality Control Linearity The calibration curves of five concentrations to mg mL were obtained by plotting the respective peak areas against concentrations. The linearity was evaluated by the linear least square regression method with three determinations at each concentration. Precision In relation to the precision of the method repeatability intra-day intermediate inter-day precision and reproducibility were investigated by performing assays of retention times peak widths at half height number of theoretical plates linear least squares regression equations and correlation coefficients for the ECD standard at five concentrations and purities for one quality control QC sample. The repeatability and intermediate precision were evaluated by one analyst within one and two days respectively while the reproducibility was achieved by two analysts Kulikov Zinchenko 2007 . Accuracy recovery The accuracy of the method was determined by the recovery test. QC samples of ECD of concentration at mg mL Cnominal were analyzed by the proposed method. Experimental values Cexp were obtained by interpolation to the linear least square regression equation of a fresh newly prepared calibration curve to mg mL and comparing with the theoretical values Cnominal . _ . Cexp mg mL __ Recovery yield C Zi mL x Limit of detection LOD and limit of quantification LOQ The LOD and LOQ of the method for impurities in ECD were determined at signal to noise ratios of 3 and 10 respectively. Stability of drug API solution The stability of the API solution was examined using the QC sample mg mL for bench-top stability study. The QC samples were kept in the autosampler at ambient temperature for HPLC analysis over three consecutive days. Experimental data were obtained by interpolation to the linear least square regression equation of a calibration curve to mg mL newly prepared each day. Retention time recovery .

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