Study of Olopatadine Hydrochloride Under Ich Recommended Stress Conditions by Lc, Lc-MS/Tof for Identification, and Characterization of Degradation Products

Mahajan, Anand A.; Mohanraj, Krishnapriya; Kale, Sandeep; Thaker, Anil

doi:10.1080/10826076.2012.704610

Cited by 8 publications

(3 citation statements)

References 3 publications

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“…Few analytical methods have been reported for the determination of OPH in pharmaceutical formulations and human biological fluids. These include HILC-MS/ MS [3,7], HPTLC [8], RP-HPLC [9][10][11], HPLC-ESI-MS/ MS [12,13], HPLC-MS/TOF [14], potentiometric sensor [15], UV-vis [6,[16][17][18][19][20][21]. The reported chromatographic and spectroscopic tools have many disadvantages such as sample pretreatment, time consuming, expensive apparatus and reagents.…”

mentioning

confidence: 99%

Electro‐elucidation and quantification of olopatadine hydrochloride in bulk form and eye drops using modification free glassy carbon electrode with its development by different electrolytes and surfactants

El‐Attar,

Abdel‐Azzem

2023

Electroanalysis

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confidence: 99%

Electro‐elucidation and quantification of olopatadine hydrochloride in bulk form and eye drops using modification free glassy carbon electrode with its development by different electrolytes and surfactants

El‐Attar,

Abdel‐Azzem

2023

Electroanalysis

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“…[3][4] During force degradation studies, two unknown degradation impurities were detected in photodegradation of Olopatadine Hydrochloride, using a newly developed gradient reversed-phase High-performance liquid chromatography method. [5][6]. Identified impurities found in Olopatadine Hydrochloride Ophthalmic Solution 0.5 % (w/v) can potentially exhibit pharmacological activity/toxicity.…”

Section: Introductionmentioning

confidence: 99%

Isolation and Characterization Photo Degradation Impurities of Drug Product Olopatadine Hydrochloride by Spectral Techniques

Jadhav¹,

Gosar²,

Jadkar³

et al. 2019

CBE

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Unknown impurities were detected during Photo degradation of Olopatadine Hydrochloride ophthalmic solution 0.5% (w/v) when analyzed using the High performance liquid chromatographic technique with Photo Diode Array Detection. For further investigation was carried out by isolating these impurities from impurity rich sample of Olopatadine Hydrochloride ophthalmic solution 0.5% (w/v) using preparative isolation technique. The Olopatadine Hydrochloride ophthalmic solution 0.5% (w/v) was subjected to photolytic forced degradation in the presence of Benzalkonium chloride and other excipients like Hypromellose, Mannitol, Hydroxypropyl, Boric acid, Kollidon 30 LP and mixture of solvents (Acetonitrile: Methanol; 1: 1 (v/v) under Ultra violet visible light. This led to the formation of the said impurities in higher concentration. This sample was then subjected to preparative HPLC for isolation of these unknown impurities. The structure of these unknown impurities was further elucidated using a different technique like Infra Ray Spectroscopy, Direct infusion (DI) Mass Spectroscopy, Ultra violet-Visible Spectroscopy, Proton Nuclear Magnetic Resonance Spectroscopy, carbon Nuclear Magnetic Resonance and Distortionless Enhancement by Polarization Transfer (DEPT) Spectroscopy which helped to confirm the structure of the impurities. Structure elucidation of the two impurities revealed that these are E and Z isomers of the Olopatadine hydrochloride Carbaldehyde. Olopatadine Z-isomer is used in the formulation of the Olopatadine Hydrochloride Ophthalmic Solution 0.5% (w/v). The minor amount of E-isomer also remains present in this solution as a potential impurity. However, the amount of E-isomer may increase in the solution form due to racemization. Hence, the respective Carbaldehyde impurities (both E and Z isomers) are forming during Photolytic degradation. This formation is happening through photolytic Norrish type-1 reaction which is elaborated in the paper.

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“…Kvantitativna analiza aktivne supstance u formulaciji i studije forsirane degradacije izvedene su i primenom RP-HPLC metode za praćenje stabilnosti [22]. Identifikacija i karakterizacija četiri degradaciona proizvoda ((11E)-11- [23]. N-oksid, kao proizvod termalne i oksidativne degradacije, identifikovan je UHPLC metodom (eng.…”

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Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography

Maksić

Tumpa²,

Popović

et al. 2016

Hem Ind

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IzvodU savremenoj farmaceutskoj analizi neke farmaceutski aktivne supstance studije forsirane degradacije imaju veliki značaj jer se iz njih može dobiti veliki broj značajnih posataka o stabilnosti leka. U ovom radu, opisano je ispitivane stabilnosti olopatadin-hidrohlorida pod utcajem stres agenasa a u cilju dobijanja podataka o njegovoj stabilnosti. Za praćenje ponašanja olopatadin-hidrohlorida primenjena je metoda tečne hromatografije hidrofilnih interakcija (eng. Hidrophilic Interaction Liquid Chromatography -HILIC). Olopatadin-hidrohlorid izložen je dejstvu kiseline, baze, povišene temperature i oksidacionog sredstva, a stepen degradacije praćen je u definisanim vremenskim intervalima. Takođe, određena je i kinetika degradacije u cilju sticanja boljeg uvida u stabilnost supstance i njen mehanizam razgradnje. Definisani su red reakcije, konstanta brzine reakcije i poluvreme degradacije nakon izlaganja dejstvu kiseline, baze i oksidacionog sredstva.Ključne reči: olopatadin-hidrohlorid; studije forsirane degradacije; kinetika degradacije; tečna hromatografija hidrofilnih interakcija.

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Study of Olopatadine Hydrochloride Under Ich Recommended Stress Conditions by Lc, Lc-MS/Tof for Identification, and Characterization of Degradation Products

Cited by 8 publications

References 3 publications

Electro‐elucidation and quantification of olopatadine hydrochloride in bulk form and eye drops using modification free glassy carbon electrode with its development by different electrolytes and surfactants

Electro‐elucidation and quantification of olopatadine hydrochloride in bulk form and eye drops using modification free glassy carbon electrode with its development by different electrolytes and surfactants

Isolation and Characterization Photo Degradation Impurities of Drug Product Olopatadine Hydrochloride by Spectral Techniques

Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography

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