The UV spectrum of ZLT in Milli-Q water had shown two ��max, one

The UV spectrum of ZLT in Milli-Q water had shown two ��max, one at 243.5 nm and other at 338.0 nm. Hence, both ��max were selected for the analysis of ZLT [Figure 2]. Figure 2 UV spectrum of pure drug ZLT in water Preparation of the calibration curve Aliquots of standard stock solution were further diluted with Milli-Q water to get the solutions of concentration Gefitinib molecular weight 1�C100 ��g/mL. The absorbances were measured at 243.5 and 338.0 nm against Milli-Q water as blank. All measurements were repeated three times for each concentration. The calibration curve was constructed by plotting mean of absorbance against corresponding concentration. Preparation of the sample solution Two commercial tablet preparations of different batch number were assayed. These were labeled to contain 80 mg of ZLT per tablet, respectively.

Twenty tablets of formulation (Zalto? tablet) containing 80 mg of ZLT were accurately weighed and powdered. The powder equivalent to 100 mg of ZLT was weighed and transferred to a 100 mL volumetric flask; 80 mL methanol was added and sonicate for 10 min. The volume was made to 100 mL with methanol. The solution was filtered through Whatman filter paper No. 01. From this filtrate, 1 mL was transferred to a 100 mL volumetric flask and diluted with Milli-Q water to 100 mL in order to obtain the final concentration of 10 ��g/mL. The absorbance was measured at 243.5 and 338.0 nm using Milli-Q water as blank. This procedure was repeated for six times. The amount of ZLT present in formulation was calculated by comparing it with standard absorbance. The results obtained are shown in Table 1.

Table 1 Assay of marketed formulations Method validation The developed method was validated as per ICH guidelines for following parameters.[11,12] Linearity The linearity was studied in the concentration range of 1�C40 ��g/mL and 5�C100 ��g/mL at 243.5 and at 338.0 nm, respectively. Linear regression data are shown in Table 2. Table 2 Linear regression data Specificity and selectivity The spectra obtained from tablet solutions were identical with that obtained from standard solution containing an equivalent concentration of ZLT. This showed that there was no any interference from excipients. Therefore, it could be said that developed method is highly selective. Recovery studies To ensure accuracy of the method, recovery studies were performed by standard addition method at 80%, 100%, and 120% level to preanalyzed samples and subsequent solutions were reanalyzed. At each level, three determinations were performed. The absorbances were measured at 243.5 and 338.0 nm using Milli-Q water as blank and the amount of drug recovered from the formulation were calculated, and the results obtained are shown in Table GSK-3 3.

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