A Stability Indicating Ion-Pair Lc Method for the Determination of Asenapine in Pharmaceuticals

Abstract

In this study, a new, simple and specific stability indicating ion-pair LC method was developed and fully validated for the determination of asenapine in tablets. The analysis was performed on an Agilent Eclipse XDB-C8 column (4.6 x 150 mm, 3.5 µm particles) at 30˚C. A mixture of phosphate buffer (pH 3, 20 mM) containing 10 mM 1-heptane sulfonic acid and acetonitrile, (60:40, v/v) at a flow rate of 1 mL min-1 was used as mobile phase. Detection was performed by a diode array detector at 220 nm. The developed method was validated according to related ICH guideline and US Pharmacopeia and it was suitable in terms of accuracy, precision, specificity, robustness and stability. The method was linear in the concentration range of 0.5-100 µg mL-1. Limit of detection and limit of quantification values were calculated as 0.0836 µg mL-1 and 0.2788 µg mL-1 , respectively. This ion-pair LC method was applied successfully for the determination of asenapine in its sublingual tablets.

Fabrication of Highly Sensitive Electrochemical Sensor Based on Chromium-Doped Ferrite Nanoparticles: Hybrid Graphene Nanosheets for the First Voltammetric Determination of Asenapine Maleate in Formulations and Human Plasma

“…LOD value at [CrFe 2 O 4 : GR]/CPE is about one order of magnitude lower than at CPE. In comparison, the achieved LOQ values in pure form at CPE and [CrFe 2 O 4 : GR]/CPE are significantly lower than previously reported values with UV-spectrophotometric, 5-9 spectrofluorimetric, 9 HPLC, [13][14][15][16][17][18][19][20][21][22] UFLC 23 and potentiometry, 24 Table II. These results specified the supreme sensitivity of the proposed SW-AdASV method for quantifying bulk ASE.M even at unmodified CPE, Tables I and II.…”

“…These values are significantly lower than those previously reported in literature. [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24] It was also successfully applied in determination of ASE.M in its brand "Saphris ® " and local "Asenapine" pharmaceutical products. This is valuable and useful for product assessment and product-toproduct comparisons.…”

“…4 Several methods were applied to estimate Asenapine in formulations and biological fluids. They included UV-spectrophotometric, [5][6][7][8][9] spectrofluorimetric, 8 LC-MS/MS, 1,[10][11][12] RP-HPLC, [13][14][15][16][17][18][19][20][21][22] RP-UFLC 23 and potentiometric methods. 24 After sublingual administration, Asenapine is absorbed with concentration peak plasma within 0.5 to 1.5 h. 25 However, its plasma concentration peaks were variable; it relied on the dose values and their single or multiple administration, sex, ages of volunteers and other factors.…”

A novel green HPTLC method for simultaneous analysis of four antipsychotics in their pharmaceutical formulations: Assessment by Eco-scale

“…AS is indicated for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar disorder (Wishart, 2018). Literature survey revealed quantification of AS by different analytical techniques as spectrophotometric method (Gandhimathi, 2012;Surekha, 2013), HPLC Managuli, 2016;Chhalotiya, 2012;Govindarajan, 2014;Karaca, 2017) and HPTLC (Patel,2015). Quetiapine fumarate (QU), whose chemical name is bis [2-(2-[4-(dibenzo [b,f] [1,4]thiazepin-11-yl)] ethoxy) ethanol] fumarate, is atypical antipsychotic, very effective for negative and positive schizophrenia, as well as cognitive impairment (D. Wishart, et al,2018).…”

PES, molecular structure, spectroscopic (FT-IR, FT-Raman), electronic (UV-Vis, HOMO-LUMO), quantum chemical and biological (docking) studies on a potent membrane permeable inhibitor: dibenzoxepine derivative

“…5TDOP is a drug for Schizophrenia and bipolar disorders. The diseases namely schizophrenia, bipolar disorders cause serious neuropsychiatric disorders along with substantial health risks in patients [ 7 , 8 ]. 5TDOP drug is approved by FDA for schizophrenia acute treatment and for the acute treatment of manic related to bipolar I disorder.…”