Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms


Author(s): Komal Patel, Komal Dhudasia, Amit Patel, Jayant Dave, and Chaganbhai Patel

Aim and Background: To develop and validate a simple, precise, accurate, and stability indicating a UV-method for estimation of Telmisartan (TELM). UV, HPLC, HPTLC, and many more experiments were carried out by taking single drug and also by combining with other drugs. However, Such type of studies was not reported. Materials and Methods: In both methods, TELM has the absorbance maxima at 296 nm. Method A involves method development and validation and Method B involves forced degradation study. In these methods, methanol was used as a solvent. Linearity was observed in the concentration range of 4–16 µg/ml. Validation experiments were performed to demonstrate system suitability, specificity, precision, linearity, accuracy, robustness, LOD, and LOQ as per International Conference on Harmonization guidelines. Furthermore stability studies of TELM were carried out under acidic, alkali, neutral, oxidation, photolytic, and thermal degradation as per stability indicating assay methods. Results: The results of analysis have been validated, and recovery studies were carried out using a standard addition method by adding specific drug amount (80%, 100%, and 120%) and show recovery studies in the range (99.26–101.26)%. Conclusion: The proposed method can be successfully applied for method development, validation, and stability study of TELM.