Forced Degradation Studies of Antipsychotic Iloperidone by UV Spectrophotometry

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Publisher: Knowledge Bylanes
Document Type: Report
Length: 1,728 words
Lexile Measure: 1370L

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Byline: Zahida Karim, Aneela Karim, Khalid Mohammed Khan, Nighat Shafi and Danya Roohi Saeed

Summary: A simple, rapid and cost-effective forced degradation study of Iloperidone was conducted by UV spectrophotometric method. Complete validation was performed for linearity, accuracy, and precision at the concentration range of 10-70 u g mL-1. Iloperidone was subjected to different stress conditions recommended by International Conference on Harmonization (ICH). The drug has been found susceptible to acidic and alkaline hydrolysis. However, no dry heat or photolytic degradation was observed. The results of the study can facilitate the stability indicating method development, selection of storage conditions and better understanding of the intrinsic stability characteristics of the drug molecule.

Keywords: Antipsychotic drug, Forced degradation, International Conference on Harmonization, Iloperidone, UV spectrophotometry, Validation

Introduction

The stability of a drug product or a drug substance is a critical parameter which may have an effect on its purity, potency, dosage forms, and efficacy. Changes in drug stability can be a risk for patient safety by formation of a toxic degradation product(s) or deliver a lower dose than expected. Forced degradation studies are designed to intentionally degrade a drug substance or drug product under different stress conditions i.e. heat, light, acid/base hydrolysis, and oxidation. Forced degradation studies are therefore, important to understand the reactivity of the drug substance, to determine degradation path-ways of drug substances and drug products (e.g. during development phase), to solve stability-related problems, and to generate more stable formulations.

Chromatographic techniques including ultra-performance liquid chromatography (UPLC) [1], HPLC-UV [2], reversed phase-HPLC [3], microemulsion liquid chromatography (MELC) [4] have been reported in the literature for the forced degradation study of different drugs.

Iloperidone is atypical antipsychotic agent and is currently used for the treatment of schizophrenia in adults [5-8]. UV-spectrophotometric methods have been used for the estimation of iloperidone in bulk and its tablet formulations [9], however, to the best of our knowledge forced degradation studies of iloperidone using UV spectrophotometry have not yet been published. The aim of this study was to develop and validate a simple, cost-effective, precise, accurate, linear and specific UV-spectrophotometric method for forced degradation study of iloperidone under different stress conditions recommended by International Conference on Harmonization (ICH).

Experimental

Materials

Iloperidone and its finished form ilodone (Genix Pharma Pvt. Ltd. Karachi, Pakistan) labeled to contain 6 mg of iloperidone was used for this study. Chloroform (purity [greater than or equal to] 99%), HCl (purity 36.5-38.0%) and NaOH (98%) were purchased from Sigma-Aldrich, USA.

Instrumentation

Double-beam UV/VIS spectrophotometer (Schimadzu, Japan) model UV-160 A was used to perform spectrophotometric study of iloperidone. For the UV-spectrophotometric study, the standard solution...

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Gale Document Number: GALE|A452061724