Abstract
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 (λ 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 (4–24 µg/ml). Accuracy of the method was evident from the % recovery values (99.50–99.87 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.
Highlights
IntroductionMianserin exhibits a protective role on the amounts of cytokine and decreases the levels of IL-6 and TNFa [4]
In UV spectrophotometric method proposed by S fair et al [6], linearity was tested in the range of 20.0140.0 μg/ml and continued study by liquid chromatographic method in which an Ace C18 column was used along with the mobile phase comprising of methanol and KH2PO4 buffer in the ratio of 85:15 v/v
Among the various existing techniques for quantitative estimation of pharmaceutical drugs, the prevalent approach is an establishment of the coloured complex involving ion-association. This method can be extended to those drugs consisting of nitrogen, which accepts a proton in an acid medium to form a cation
Summary
Mianserin exhibits a protective role on the amounts of cytokine and decreases the levels of IL-6 and TNFa [4] It exhibits antinociceptive effect along with antidepressant activity and it was suggested as a substitute to treat both mood disorders and neuropathic pain associated with diabetes [5]. It is clear from the literature survey that reports were published for its quantitative determination using various analytical methods. Taking into consideration of the cost of the chromatographic/electrophoresis instruments and difficulty in the maintenance of reaction conditions for the above spectrophotometric methods, in the present study, TPooo was used as a chromogen to develop colour for its determination both in bulk drug and dosage forms
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