Abstract
Simple, precise, selective, and expeditious spectrophotometric methods have been developed for the determination of itopride (ITO), midodrine (MID), diclofenac (DIC), mesalamine (MES), and sumatriptan (SUM) in their pure form as well as in pharmaceutical preparations. The method was based on ion-pair complex formation between the drugs and anionic dye, bromothymol blue in an acidic medium (pH 2.0–4.0). The yellow colored complexes formed were quantitatively extracted into chloroform and measured at 411, 410, 413, 412, and 414 nm wavelength for ITO, MID, DIC, MES, and SUM, respectively. Beer’s law was obeyed in the concentration range of 3.0–30 µg/mL for ITO, 1.0–20 µg/mL for MID, 1.5–40 µg/mL for DIC, 1.2–12 µg/mL for MES, and 0.5–15 µg/mL for SUM. The stoichiometry of the complexes formed between the drugs and the dye was 1:1 as determined by Job’s method of continuous variation. The association constant (KIP) of the ion-pair complexes formed was evaluated using Benesi–Hildebrand equation. Limit of detection, limit of quantification, and Sandell’s sensitivity of the methods were also estimated. The proposed methods were successfully employed for the determination of these drugs in their pharmaceutical dosage forms.
Highlights
Spectrophotometry-based methods are widely used for the analysis of bulk drugs and in the quality control of marketed pharmaceutical dosage forms as they are much simpler, rapid, cost-effective, and less labor intensive in comparison to other methods
Literature presents several extractive spectrophotometric methods based on ion-pair complex formation for the estimation of drugs in their pharmaceutical preparations
The ion-pair complexes formed by interaction of basic moieties having primary, secondary, or tertiary amino group with different anionic dyes in aqueous medium can be readily extracted into immiscible organic diluents
Summary
Spectrophotometry-based methods are widely used for the analysis of bulk drugs and in the quality control of marketed pharmaceutical dosage forms as they are much simpler, rapid, cost-effective, and less labor intensive in comparison to other methods These method provide accurate, precise, and fast results and find extensive use, especially when expensive equipments like HPLC, HPTLC, GC, and electrophoresis are not accessible (Gouda, Kotb El-Sayed, Amin, & El Sheikh, 2013; Rojas & Ojeda, 2009; Siddiqui, Alothman, & Rahman, 2013). Itopride (ITO) hydrochloride, a benzamide derivative is novel gastroprokinetic agent which possess acetylcholine esterase inhibitory (ACHE) as well as dopamine D2 receptor antagonist activity It is useful for the symptomatic treatment of various gastrointestinal disorders, including functional dyspepsia and gastroesophageal reflux disease (Yoon et al, 2014). It functions by increasing acetylcholine concentrations which lowers the esophageal sphincter pressure, stimulates gastric motility, accelerates gastric emptying, and improves gastroduodenal coordination (Huang, Lv, Zhang, Fan, & Meng, 2012)
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