Validated UV spectrophotometric method for quantitative determination of agomelatine coated tablets dosage form
Keywords:Agomelatine, Method development, UV spectroscopy, Validation, ICH Q2 (R1)
Objective: 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. Methods: 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. Results: 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 %. Conclusion: The proposed method is definite, meticulous, reproducible and can be used for routine analysis of Agomelatine in bulk and pharmaceutical dosage form.
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