TY - JOUR AU - V. Koti Reddy, AU - K. Venkata Ramana, PY - 2022/01/02 Y2 - 2024/03/28 TI - Validated UV spectrophotometric method for quantitative determination of agomelatine coated tablets dosage form: https://doi.org/10.54037/WJPS.2022.100110 JF - World Journal of Pharmaceutical Sciences JA - World J Pharm Sci VL - 10 IS - 01 SE - Research Article DO - UR - https://wjpsonline.com/index.php/wjps/article/view/validated-uv-spectrophotometric-determination-agomelatine SP - 98-103 AB - <p><strong>Objective</strong>: To develop and validate simple, definite, stability indicating UV spectroscopic method for determination of Agomelatine coated tablet and pharmaceutical formulations as per ICH Q2 R1 Guidelines. <strong>Methods</strong>: Agomelatine was subjected to different stress conditions as per ICH guideline Q1A (R2). A UV spectroscopic method is validated with different parameters such as linearity, Precision, Repeatability, Limit of Detection (LOD) and Limit of Quantification (LOQ), Accuracy, Robustness, Ruggedness. It involved a 2-h study in which methanol were used as solvents. <strong>Results</strong>: Agomelatine in methanol shows maximum absorbance at 229 nm. Beer's law was obeyed in the concentration range of 0.2- 1.0 mcg/mL. The LOD and LOQ were found to be 0.00271 mcg/ml and 0.0082 mcg/ml respectively. A recovery of Agomelatine in tablet formulation was observed in the range of 98.00-102.00%. Percentage assay of Agomelatine was found to be more than 99.93 %. <strong>Conclusion</strong>: The proposed method is definite, meticulous, reproducible and can be used for routine analysis of Agomelatine in bulk and pharmaceutical dosage form.</p> ER -