DETERMINATION OF MIANSERIN USING TROPAEOLIN-OOO BY ION PAIR FORMATION
Keywords:Mianserin, Tropaeolin-ooo, Ion associative complex, Assay, Method Development, Validation
Objective: The present study was aimed at the development of a simple visible spectrophotometric method for the assay of mianserin, a drug used for the treatment of depression.
Methods: The method was developed using tropaeolin-ooo (TPooo) as an ion associative complex forming a chromophore. Developed the chromophore by sequential mixing of aqueous solutions of mianserin, hydrochloric acid, and TPooo. Chromophore was extracted into an organic solvent (chloroform) and absorbance values of organic layers were measured. As per the existing guidelines of an international conference on harmonization (ICH), various parameters of the method were tested for validation.
Results: At the optimized reaction conditions, the formed chromophore (Î» max 524 nm) was stable and sensitive. Regression analysis (r>0.9999) shows that the plotted calibration curve exhibits good linearity in the studied range of concentration (4â€“24 Âµg/ml). Accuracy of the method was evident from the % recovery values (99.50â€“99.87 range). Satisfactory precision (both intra and inter day) for the proposed method was clear as ranges of percentage of relative standard deviation (%RSD) values were 1.382-1.781 and 1.128-1.765 respectively. Since RSD is less than 2 %, this method was reproducible and accurate.
Conclusion: Due to lack of pre-treatment process for this method, it was simple. All the tested parameters of the method were validated as per ICH guidelines.
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