Data of degradation Axitinib melanoma studies is shown in Table 2. The %RSD of replicate determination percent area was found to be <5% in both precision and intermediate precision, which indicates that the method is precise. The data of precision studies is shown in Tables Tables3a3a and andb.b. The results obtained from the recovery study were found within the range of 90% to 110% (LOQ to 150%), which indicates that method is accurate, and data for the same is shown in Table 4. Sensitivity of the method was verified and the method was found to be linear, accurate, and precise at LOQ. The data of LOD and LOQ studies is given in Tables Tables3a3a and andb.b. The calibration curves of all impurities were obtained by plotting the peak area of individual impurity versus concentration over the range of about 0.

02�C2 ��g/mL and were found to be linear (r=0.999). The data of regression analysis of the calibration curves is shown in Table 3. The impurity content in the in-house formulations was found to be satisfactory. Table 1 System suitability Table 2 Specificity Table 3a Regression and precision data Table 3b Regression and precision data Table 4 Evaluation of accuracy CONCLUSION Although liquid chromatography is a versatile technique for the analysis of drug in complex matrices such as biological or pharmaceuticals, a number of analytical approaches have been previously described to determine candesartan cilexetil in biological materials and pharmaceutical preparations. However, this is the first study reporting a validated reversed phase method for quantification of all impurities as well as degradents in candesartan cilexetil formulation.

The simple UPLC method developed in this study makes it suitable for separation and estimation of impurities without interference from excipients and other related substances present in the pharmaceutical matrices. The analytical performance and the results obtained from analysis of two different formulations demonstrated that the method is reliable and sufficiently robust. In conclusion, the high sensitivity, good selectivity, accuracy, and reproducibility of the UPLC method developed in this study makes it suitable for quality control analysis of complex pharmaceutical preparations containing candesartan cilexetil and its impurities. The reduction of acetonitrile consumption is one of the best solutions to the current global acetonitrile shortage and will safeguard against future risk.

ACKNOWLEDGMENTS We wish to express our sincere thanks to the management of Dr. Reddy’s Laboratories, Hyderabad, India, for their support and encouragement. The authors�� Intellectual Property Management department (IPM) has given this manuscript the internal Brefeldin_A publication number PUB-00132-11. Footnotes Source of Support: Nil Conflict of Interest: None declared.
The proposed method was validated according to the International Conference on Harmonization (ICH) guidelines.