• Giri Prasad Gorumutchu Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar 522510, India
  • Venkata Nadh Ratnakaram GITAM University – Bengaluru, Karnataka 562163, India



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 (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.


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Hamadjida A, Nuara SG, Gourdon JC, Huot P. The effect of mianserin on the severity of psychosis and dyskinesia in the parkinsonian marmoset. Prog Neuropsychopharmacol Biol Psychiatry 2018;81:367-71.

Yang M, Liu S, Hu L, Zhan J, Lei P, Wu M. Effects of the antidepressant mianserin on the early development of fish embryos at low environmentally relevant concentrations. Ecotoxicol Environ Saf 2018;150:144-51.

Hamadjida A, Nuara SG, Gourdon JC, Huot P. The effect of mianserin on the severity of psychosis and dyskinesia in the parkinsonian marmoset. Prog Neuro-Psychopharmacol Biol Psychiatry 2018;81:367-71.

Manikowska K, MikoÅ‚ajczyk M, MikoÅ‚ajczak PÅ, Bobkiewicz KozÅ‚owska T. The influence of mianserin on TNF-α, IL-6 and IL-10 serum levels in rats under chronic mild stress. Pharmacol Rep 2014;66:22-7.

Ucel UÄ°, Can OD, Ozkay UD, Ozturk Y. Antihyperalgesic and antiallodynic effects of mianserin on diabetic neuropathic pain: a study on mechanism of action. Eur J Pharmacol 2015;756:92-106.

Sfair LL, Graeff JS, Steppe M, Schapoval EES. Ultraviolet spectrophotometric method for analytical determination of mianserin hydrochloride in coated tablets and comparison with LC. Braz J Pharm 2015;51:833-7.

Farag RS, Afifi MS, Abd-Rabow MM. Extractive spectrophotometric determination of mianserin hydrochloride by acid-dye complexation method in pure and in pharmaceutical preparations. Int J Pharm Sci Res 2011;2:1197-203.

Han IU, Aman T, Kazi AA, Khan ZA. Spectrophotometric determination of mianserin in pure and pharmaceutical preparations. J Chem Soc Pakistan 2002;24:114-8.

Devani MB, Pandya SS, Shah SA. Spectrophotometric determinations of mianserin hydrochloride with 3-methyl-2-benzothiazolinonehydrozone. J Pharm Pharm 1990;52:123-4.

Xu P, Chen BM, Ma N, Yan M, Zhu YG. Determination of mianserin in human plasma by high-performance liquid chromatography–electrospray ionization mass spectrometry (HPLC–ESI/MS): application to a bioequivalence study in Chinese volunteers. J Pharm Biomed Anal 2008;47:994-9.

Åukaszkiewicz J, Piwowarska J, SkarzyÅ„ska E, Åojewska MS, Pachecka J. Development validation and application of the HPLC method for determination of mianserin in human serum. Acta Pol Pharm 2007;64:103-7.

Hefnawy MM, Aboul Enein HY. Fast high performance liquid chromatographic analysis of mianserin and its metabolites in human plasma using monolithic silica column and solid-phase extraction. Anal Chim Acta 2004;504:291-7.

Sun LL, Si TM, Shu LA, Zhang HY, Tian CH. HPLC determination of mianserin in human plasma. Zhongguo-Xinyao-Zazhi 2002;11:714-6.

Grodner B, Pachecka J. A simpler and faster capillary electrophoresis method for determination of mianserin enantiomers in human serum. Acta Pol Pharm 2006;63:9-14.

Martinez MA, Sanchez de la Torre C, Almarza E. A comparative solid-phase extraction study for the simultaneous determination of fluvoxamine, mianserin, doxepin, citalopram paroxetine, and etoperidone in whole blood by capillary gas-liquid chromatography with nitrogen-phosphorus detection. J Anal Toxicol 2004;28:174-80.

Andersen S, Halvorsen TG, Pedersen S, Rasmussen KE. Liquid-phase micro-extraction combined with capillary electrophoresis, a promising tool for the determination of chiral drugs in biological matrices. J Chromatogr 2002;963:303-12.

Wang F, Khaledi MG. Capillary electrophoresis chiral separation of basic pharmaceutical enantiomers with different charges using sulfated beta-cyclodextrin. J Microcolumn Sep 1999;11:11-21.

Ishii A, Kurihara R, Kojima T, San T, Mizuno Y, Yamakawa Y, et al. Sensitive determination of mianserin and setiptiline in body fluids by gas chromatography with surface ionization detection (GC-SID). Int J Legal Med 2000;2:115-8.

Lewis J, Cairncross KD. A simplified method for the estimation of mianserin in plasma. Br J Clin Pharmacol 1981;12:583-5.

Kiran Kumar K, Venkata Nadh R, Nagoji KEV. Extractive spectrophotometric determination of nicergoline through ion-pair complexation reaction. Oriental J Chem 2013;29:263-9.

Sethi PD. HPLC quantitative analysis of pharmaceutical formulations. CBS publications, India; 2001.

ICH guidelines, Validation of Analytical Procedures. Text and Methodology. Q2 (R1); 2015. p. 8-13.

Sudhir MS, Nadh RV. Diazo-coupling a facile mean for the spectrophotometric determination of rasagiline hemitartrate. Oriental J Chem 2014;29:1507-14.

Kumar KK, Nadh RV, Nagoji KE. Determination of bendamustine hydrochloride in pure and dosage forms by ion-associative complex formation. Oriental J Chem 2014;30:905-10.

Kulkarni Manasi B, Joshi Anagha M. An experimental design approach for optimization of the modified colorimetric first-order derivative method for estimation of serralysin in bulk and pharmaceutical formulation. Asian J Pharm Clin Res 2018;11:293-300.

Akram M, El-Didamony, Monuir Z, Saad Nora O, Saleem. Extractive-spectrophotometric determination of some antimuscarinic antagonist in tablet formulations using eriochrome cyanine R. Int J Pharm Pharm Sci 2018;10:2-28.

Sharma DK, Jasvir Singh, Pushap Raj. Spectrophotometric determination of propranolol hydrochloride and metoprolol tartrate in pharmaceutical dosage forms, spiked water, and biological fluids. Int J Pharm Pharm Sci 2018;10:107-15.

Godambe RD, Disouza JI, Jamkhandi CM, Kumbhar PS. Development of spectrophotometric and fluorometric methods for estimation of darunavir using Qbd approach. Int J Curr Pharm Res 2018;10:13-9.



How to Cite

Gorumutchu, G. P., & Ratnakaram, V. N. (2019). DETERMINATION OF MIANSERIN USING TROPAEOLIN-OOO BY ION PAIR FORMATION. International Journal of Applied Pharmaceutics, 11(1), 168–173.



Original Article(s)