Isolation, identification and characterization of two novel process-related impurities in olanzapine

Zhuang, Tao; Zhang, Wen; Cao, Lushuai; He, Kai; Wang, Yu; Li, Jing; Chen, Liang; Liu, Bi‐Feng; Zhang, Guisen

doi:10.1016/j.jpba.2018.01.026

Cited by 19 publications

(7 citation statements)

References 18 publications

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“…Olanzapine (OLZ), 2-methyl-4-(4-methyle-1piperazinyl)-10H-thieno(2,3b)(1,5) benzodiazepine (37,38), is a second-generation atypical antipsychotic drug approved by the Food and Drug Administration (FDA) as a first-line therapy for the treatment of schizophrenia, acute mania with bipolar disorder, agitation, and psychotic symptoms in dementia (39)(40)(41)(42)(43). Schizophrenia is a severe and chronic psychotic disorder, considered the most disabling psychiatric disorders with enormous economic and social impact (44).…”

Section: Introductionmentioning

confidence: 99%

“…Schizophrenia is a severe and chronic psychotic disorder, considered the most disabling psychiatric disorders with enormous economic and social impact (44). OLZ is known to bind and antagonize copious receptors such as dopamine (D1, D2, D3, and D4); 5HT2 a , 5HT2 c , 5HT3, and 5HT6; histamine at H1 receptors; and alpha-1 adrenergic receptors (38,45,46) . Despite its vast applications in psychotic disorders, OLZ have an issue of poor water solubility that leads to unreliable absorption and erratic pharmacokinetic profiles (41,47).…”

Section: Introductionmentioning

confidence: 99%

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RETRACTED ARTICLE: Poloxamer-407-Co-Poly (2-Acrylamido-2-Methylpropane Sulfonic Acid) Cross-linked Nanogels for Solubility Enhancement of Olanzapine: Synthesis, Characterization, and Toxicity Evaluation

2020

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Current study is focused to enhance the solubility of poorly soluble drug olanzapine (OLZ) by nanogels drug delivery system, as improved solubility is one of the most important applications of nanosystems. Poor solubility is a major issue, and 40% of marketed and about 75% of new active pharmaceutical ingredients are poorly water soluble which significantly affect the bioavailability and therapeutic effects of these drugs. In this study, nanogels, a promising system for solubility enhancement, were developed by freeradical polymerization technique. Different formulations were synthesized in which poloxamer-407 was cross-linked with 2-acrylamido-2-methylpropane sulfonic acid (AMPS) with the help of cross-linker methylene bisacrylamide (MBA). The chemically cross-linked nanogels were characterized by Fourier transform infrared spectroscopy (FT-IR), thermos gravimetric analysis (TGA), differential scanning calorimetry (DSC), X-ray diffraction (XRD), scanning electron microscopy (SEM), zeta size, swelling, sol-gel analysis, drug loading, solubility, and in vitro drug release studies. In order to determine the biocompatibility and cytotoxicity of nanogels to biological system, toxicity study on rabbits was also carried out. It was confirmed that the developed nanogels was thermally stable, safe, effective, and compatible to biological system, and the solubility of olanzapine (OLZ) was enhanced up to 38 folds as compared with reference product.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

RETRACTED ARTICLE: Poloxamer-407-Co-Poly (2-Acrylamido-2-Methylpropane Sulfonic Acid) Cross-linked Nanogels for Solubility Enhancement of Olanzapine: Synthesis, Characterization, and Toxicity Evaluation

2020

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“…Different techniques for impurity profiling, include coupling of CE with varying MS ionization systems such as electrospray ionization (ESI-MS), atmospheric pressure chemical ionization (APCI-MS), atmospheric pressure photoionization (APPI-MS) and thermospray ionization (TSI-MS). The ESI-MS and TSI-MS are useful for detecting the ionic compound whereas; the APCI-MS and APPI-MS are not capable of detecting the ionic sample [66][67][68][69][70][71][72] . Accordingly, it can be also aid to differentiate between the ionic or non-ionic unknown impurity.…”

Section: Capillary Zone Electrophoresis-mass Spectrometry (Cze-ms)mentioning

confidence: 99%

A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

Parmar¹,

Shaik²

2021

ijps

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Parmar et al.: Recent Analytical Techniques for Characterization of ImpuritiesImpurity is an unwanted substance present in the active pharmaceutical ingredients that form during the synthesis process of active pharmaceutical ingredients or any unwanted constituent that is produced besides the active ingredient during the formulation or the aging of active pharmaceutical ingredients. Even the insignificant quantity of impurity existing in the medicinal product may harm the patient life and compromises the purity and superiority of the medicinal product. According to International council for harmonisation guidelines, analytical monitoring of impurity is a prerequisite and mandatory requirement for approval of market authorization of the new drug substance. Any pharmaceutical product would be capable to serve their intended therapeutic activity when they are free from impurity. Thus, an impurity existing in an active pharmaceutical ingredient needs to be identified and quantify with the help of modern analytical approaches. This review explores the basic information concerning impurity profiling, highlights the advantages of an analytical technique and also focuses on the limitation of different analytical methods for impurity profiling with possible ways to overcome the limitation.

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“…To meet this stringent regulatory requirements the impurity profile study has to be carried out for the final API to identify and characterize the unknown impurity that is present at > 0.1%. This paper demonstrates the isolation and structure elucidation of impurity present in the API of Nebivolol using preparative HPLC through chiral separation of Nebivolol bulk drug 5,7 .…”

Section: Introductionmentioning

confidence: 99%

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2021

IJPSR

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Isolation, identification and characterization of two novel process-related impurities in olanzapine

Cited by 19 publications

References 18 publications

RETRACTED ARTICLE: Poloxamer-407-Co-Poly (2-Acrylamido-2-Methylpropane Sulfonic Acid) Cross-linked Nanogels for Solubility Enhancement of Olanzapine: Synthesis, Characterization, and Toxicity Evaluation

RETRACTED ARTICLE: Poloxamer-407-Co-Poly (2-Acrylamido-2-Methylpropane Sulfonic Acid) Cross-linked Nanogels for Solubility Enhancement of Olanzapine: Synthesis, Characterization, and Toxicity Evaluation

A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

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