A Validated Stability Indicating Uplc Method for Simultaneous Determination of Assay, Related Substances, and Degradation Products of Paliperidone Palmitate Active Pharmaceutical Ingredient and Its Pharmaceutical Injection Forms

Bindu, K. Hima; Dhekale, Nitin H.; Suryanarayana, M.; Anjaneyulu, Y.

doi:10.1080/10826076.2011.601503

Cited by 11 publications

(5 citation statements)

References 4 publications

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“…The photodegradation of paliperidone was not studied thoroughly so far and mainly papers concerning the development of stability‐indicating method for the analysis of this drug by the use of UPLC‐DAD (Bindu et al ., , ) and LC‐UV (Dadare et al ., ; Mathew et al ., ) have been published. In these papers paliperidone was found to be a photostable compound and only Mathew et al noticed 9% degradation of this drug after 24 h irradiation at UV 275 nm, but no identification of degradation product was performed in this case.…”

Section: Introductionmentioning

confidence: 99%

Characterization of paliperidone photodegradation products by LC‐Q‐TOF multistage mass spectrometry

Skibiński

Komsta

Inglot

2015

Biomedical Chromatography

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The photodegradation of paliperidone in aqueous and methanol media under UVA and UVC irradiation was investigated. The identification and structural elucidation of its photodegradation products were performed by the use of the reversed-phase liquid chromatography coupled with accurate mass hybrid Q-TOF mass spectrometry and an atmospheric pressure chemical ionization source. Five degradation products were found and their masses were obtained with high accuracy (1.10-5.26 ppm) based on the TOF (MS) spectra. For the structural elucidation of unknown degradation products MS/MS spectra were also registered. However, for the identification of the main photodegradation product (3-{2-[4-(6-fluoro-1,3-benzoxazol-2-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one) in-source fragmentation connected with collision-induced dissociation was used and MS(3) spectra were finally performed. The photodegradation of paliperidone yields the first-order kinetics in all tested conditions. The aqueous medium was in this case much less stable than the methanol solvent regardless of the irradiation source. Additionally, the toxicity of the analyzed photodegradation products was predicted by the use of ECOSAR software and comparable values of LC50 for the main degradants and the parent compound were obtained. Copyright © 2015 John Wiley & Sons, Ltd.

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Section: Introductionmentioning

confidence: 99%

Characterization of paliperidone photodegradation products by LC‐Q‐TOF multistage mass spectrometry

Skibiński

Komsta

Inglot

2015

Biomedical Chromatography

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“…They enhance the resolution and detection by increasing the column efficiency and capacity and reduce the analysis time as well as solvent consumption. 7,8 The best approach for the optimization of multiple factors is a two-level factorial design by Design Expert. [9][10][11] The evolution of robustness should be considered during development phase by building it into the method rather than tested at the end of the method.…”

Section: Introductionmentioning

confidence: 99%

Development and optimization of a multivariate RP-UPLC method for determination of telmisartan and its related substances by applying a two-level factorial design approach: application to quality control study

et al. 2014

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“…An extensive literature survey is carried out and very few spectrophotometric 6 methods were found so far. Some LC-MS/MS methods 7,8 , HPTLC methods 9,10 , HPLC method 11,12 and a UPLC method 13 for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in plasma, urine and pharmaceutical formulations respectively are available. We report two spectrophotometric methods for the determination of the drug.…”

Section: Introductionmentioning

confidence: 99%

Spectrophotometric Methods for the Quantitative Estimation of Paliperidone in Formulations

2014

Chem Sci Trans

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Two simple, sensitive and economical spectrophotometric methods have been developed and validated for the determination of paliperidone in pharmaceutical dosage forms. The methods were based on the formation of colored complex of Paliperidone with different reagents. The absorbance of the formed colored complex is measured at the wavelength of maximum absorbance of the complex 665 nm and 555 nm respectively against the reagent blank treated similarly. These methods have different linearity ranges observed in the concentration ranges of 1-6 and 10-60 μg/mL with correlation coefficient of 0.998 for both the methods. Statistical analysis indicates that the proposed methods are reproducible and selective for the estimation of Paliperidone in bulk drug and in its tablet dosage form.

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A Validated Stability Indicating Uplc Method for Simultaneous Determination of Assay, Related Substances, and Degradation Products of Paliperidone Palmitate Active Pharmaceutical Ingredient and Its Pharmaceutical Injection Forms

Cited by 11 publications

References 4 publications

Characterization of paliperidone photodegradation products by LC‐Q‐TOF multistage mass spectrometry

Characterization of paliperidone photodegradation products by LC‐Q‐TOF multistage mass spectrometry

Development and optimization of a multivariate RP-UPLC method for determination of telmisartan and its related substances by applying a two-level factorial design approach: application to quality control study

Spectrophotometric Methods for the Quantitative Estimation of Paliperidone in Formulations

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