Abstract
abstract Ultraviolet spectrophotometric (UV) and Liquid Chromatographic (LC) methods for the determination of mianserin hydrochloride in pharmaceutical formulation were developed and validated. The various parameters, such as specificity, linearity, precision and accuracy were studied according to International Conference on Harmonization (ICH, 2005). For UV method, mianserin hydrochloride was determinate at 278 nm using HCl 0.1 M as the solvent. The response was linear in the concentration range of 20.0 - 140.0 µg/mL (r = 0.9998). Precision data evaluated by relative standard deviation was lower than 2%. The UV method was simple, rapid and low cost. Chromatographic analyses were performed in an Ace C18 column and the mobile phase was composed of methanol, 50 mM monobasic potassium phosphate buffer and 0.3% triethylamine solution adjusted to pH 7.0 with phosphoric acid 10% (85:15). LC method was specific, linear, precise, exact and robust. The results confirmed that the both methods are valid and useful to the routine quality control of mianserin hydrochloride in coated tablets. Statistical analysis by Student´s t-test showed no significant difference between the results obtained by UV and LC methods.
Highlights
Mianserin hydrochloride (Figure 1), chemically (RS)-2-methyl-1,2,3,4,10,14b -hexahydrodibenzo[c,f] pyrazino[1,2-α]azepine hydrochloride, is a drug for the treatment of depressive illness and depression associated with anxiety
The antidepressant mianserin hydrochloride exhibits a tetracyclic structure that is different from typical tricyclic antidepressants
Based on its mechanism of action not defined, mianserin is classified as an atypical antidepressant (Pawlowska et al, 2003)
Summary
Mianserin hydrochloride (Figure 1), chemically (RS)-2-methyl-1,2,3,4,10,14b -hexahydrodibenzo[c,f] pyrazino[1,2-α]azepine hydrochloride, is a drug for the treatment of depressive illness and depression associated with anxiety. The antidepressant mianserin hydrochloride exhibits a tetracyclic structure that is different from typical tricyclic antidepressants. Based on its mechanism of action not defined, mianserin is classified as an atypical antidepressant (Pawlowska et al, 2003). It is metabolized mainly by N-demethylation, aromatic hydroxylation, N-oxidation and N-glucuronidation. The major metabolite of mianserin hydrochloride in plasma, N-desmethylmianserin, contributes substantially to the overall therapeutic effects of mianserin in patients (Chauhan et al, 2005).
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