Abstract
Objective: Three sensitive, simple, precise, reproducible, and validated spectrophotometric methods have been developed for the determination of anti-psychotic drug (asenapine maleate) in pure and pharmaceutical dosage forms.
 Methods: The methods are based on the formation of yellow-colored ion-pair complex between asenapine maleate and three acid dyes, namely, bromocresol purple (BCP), bromophenol blue (BPB) and bromothymol blue (BTB) with absorption maxima at 410, 414 and 416 nm, respectively. Several parameters such as pH, buffer type and volume, reagent volume, the sequence of addition and effect of extracting solvent were optimized.
 Results: Under the optimum experimental conditions, beer’s law is obeyed over the concentration ranges of 1.0–20, 1.0–14, and 1.0-16 μg/ml for BCP, BPB and BTB, respectively, with good correlation coefficients (0.9994-0.9998). The apparent molar absorptivity and Sandell’s sensitivity values are reported for all methods. The limit of detection (LOD) and the limit of quantification (LOQ) values are found to be 0.27, 0.30, and 0.25 μg/ml and 0.90, 1.0, and 0.83 μg/ml for BCP, BPB and BTB, respectively. The stoichiometric ratio of the formed ion-pair complexes was found to be 1:1 (drug: reagent) for all methods, as deduced by Job's method of continuous variation.
 Conclusion: The proposed methods were successfully applied for the determination of asenapine maleate in pharmaceutical formulations with good accuracy and precision. Statistical comparison of the results was performed using Student's t-test and variance ratio F-test at the 95% confidence level and there was no significant difference between the reported and proposed methods regarding accuracy and precision. Further, the validity of the proposed methods was confirmed by recovery studies via standard addition technique in accordance with ICH guidelines.
Highlights
Asenapine Maleate (ASP) is chemically designated as (3aRS,12bRS)rel-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz (2,3:6,7) oxepino4,5-c] pyrrole maleate [1]
The absorption spectra of the ion-pair complexes, which were formed between ASP and reagents, were measured in the range 350–550 nm against the blank solution and the maximum absorbances were measured at wavelengths 410, 414, and 416 nm using bromocresol purple (BCP), bromophenol blue (BPB), and bromothymol blue (BTB), respectively
The results indicate that the molar ratio of (ASP: dye) is (1:1) ion-pair complex are formed through the electrostatic attraction between the positively charged ASP+and negatively charged dye, (BCP−, BPB−, and BTB−)
Summary
Asenapine Maleate (ASP) is chemically designated as (3aRS,12bRS)rel-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz (2,3:6,7) oxepino4,5-c] pyrrole maleate (fig. 1) [1]. The literature survey revealed that many methods were described for the determination of ASP in pure, tablet dosage forms and biological fluids such as spectrofluorimetry [3], highperformance liquid chromatography (HPLC) [4,5,6,7,8,9,10,11,12,13,14,15], stability indicating HPLC methods [16,17,18,19,20,21], thin layer chromatography [22], gas chromatography [23], potentiometry [24] and titrimetric method [25] Most of these reported methods are either not appropriately sensitive or tedious and utilized expensive instruments that are not available in most quality control laboratories. Visible spectrophotometry is considered as the most convenient analytical technique in most quality control and clinical laboratories, hospitals and pharmaceutical industries for the assay of different classes of drugs in pure form, pharmaceutical formulations and biological samples, due to its simplicity, less expensive, less time consuming and reasonable sensitivity with significant economic advantages
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