Intermediate precision

Intermediate precision selleck Sunitinib (Inter-day and intra-day variation) Measurements of inter-day and intra-day variation of BH and TB solutions were observed in triplicate on three consecutive days determined the intermediate precision [Tables [Tables22 and and33]. Table 2 Intermediate precision (inter-day) Table 3 Intermediate precision (intra-day) Reproducibility The reproducibility of the method was checked by determining precision on the same instrument, but by a different analyst. For both intra-day and inter-day variation, solutions of BH and TB at concentrations (25 ��g/ml) were analyzed in triplicate. LOD and LOQ In order to estimate the limit of detection (LOD) and limit of quantitation (LOQ) values, the blank sample was injected six times and the peak area of this blank was calculated as a noise level.

The LOD was calculated as three times the noise level while ten times the noise value gave the LOQ. Robustness The robustness of the method was determined to assess the effect of small but deliberate variation of the chromatographic conditions on the determination of BH and TB. Robustness was determined by using reagents from two different lots and two different manufacturers. Sample solution stability The stability of the drug in solution during analysis was determined by repeated analysis of samples during the course of experimentation on the same day and also after storage of the drug solution for 72 h under laboratory bench conditions (25 �� 1��C) and under refrigeration (8 �� 0.5��C). The solution was subjected to HPLC analysis immediately and after a period of 24, 48, and 72 h.

There were no significant changes in the analyte composition over a period of 72 h. The mean RSD between peak areas, for the sample stored under refrigeration (8 �� 0.5��C) and at a laboratory temperature (25 �� 1��C), was found to be 0.159% and 0.234% for BH and TB, respectively. The method suggesting that drug solution can be stored without any degradation over the time interval suggested. Specificity/selectivity The specificity test of the proposed method demonstrated that the excipients from tablets do not interfere in the drug peak. Furthermore, well-shaped peaks indicate the specificity of the method. Better resolution was found for the drug peak with no interference proved that the method was found to be selective to the drug. System suitability tests The chromatographic systems used for analyses must pass the system suitability limits before sample analysis can commence. The injection repeatability for the principal peak Anacetrapib was the parameters tested on a 25 ��g/ml sample of BH and TB to assist the accuracy and precision of the developed HPLC system.

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