Identification, isolation and characterization of potential degradation product in risperidone tablets

Bharathi, Ch.; Chary, D. Krishnama; Kumar, M. Saravana; Shankar, Rama; Handa, V. K.; Dandala, Ramesh; Naidu, A.

doi:10.1016/j.jpba.2007.08.008

Cited by 9 publications

(3 citation statements)

References 10 publications

(9 reference statements)

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“…Besides the above examples, gradient elution methods also have been developed for measuring donepezil hydrochloride and its impurities in oral pharmaceutical formulations (248) and for studying the degradation of risperidone in tablets (249). These methods have been used, respectively, to study the kinetics of degradation and to isolate and identify the major degradation product in the pharmaceuticals.…”

Section: Separation-based Methodologymentioning

confidence: 99%

Pharmaceuticals and Related Drugs

Gilpin

Pachla

2009

Anal. Chem.

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Section: Separation-based Methodologymentioning

confidence: 99%

Pharmaceuticals and Related Drugs

Gilpin

Pachla

2009

Anal. Chem.

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“…Risperidone has been classified as a “qualitatively atypical” antipsychotic medicine that is commonly used for the treatment of schizophrenia, the mania of bipolar disorder and irritability and aggression autism (Rostama et al, 2020). A literature review reveals that there are analytical methods available in various pharmacopeias (USP, European Pharmacopeia, Japanese Pharmacopeia and Chinese Pharmacopeia) and research articles for the analysis of risperidone and its impurities in drug substances and drug products (Bharathi et al, 2008; Bhusnure et al, 2015; Chen et al, 2015; Danel et al, 2007; Ezzeldin et al, 2017; Rub et al, 2020; Schatz & Saria, 2000; Suthar et al, 2009). Most of the methods are on HPLC with long run times and do not cover assay of active pharmaceutical ingredient (API) and all the impurities in single method.…”

Section: Introductionmentioning

confidence: 99%

Application of the “Method Operable Design Region” (MODR) approach for the development of a UHPLC method for the assay and purity determination of risperidone in risperidone drug substance and other formulations

Amit

Nancy

2022

Biomedical Chromatography

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To understand the role of analytics in drug development, regulatory bodies also started using the approach of Quality by Design (QbD) during analytical method developments. The present study deals with the development of the “Method Operable Design Region” for assay and purity determination of risperidone in risperidone drug substance and formulations usingy UHPLC. Five different column chemistries, five different pH buffers, oven temperatures from 25 to 45°C, and different organic modifier composition, column lengths and flow rates were studied and statistically evaluated using Fusion QbD software. The final method parameters were selected by performing multivariable changes in a single run and evaluated using the Monte Carlo simulation approach. The uniqueness of this method is that it is mass compatible, a total of 10 peaks are separated within a short run time of 12.0 min and it uses a “Platforming approach”, which means the use of a single method for testing the drug substance, different strengths of a drug product and different formulations. The same method can be also used for the determination of the preservative (benzoic acid) in risperidone 1 mg/ml oral solution. The use of the QbD approach is aligned with the US Pharmacopeia <1220>, BP supplementary chapter 2022 and the International Conference on Harmonization Q14 guidelines for life cycle management of analytical methods.

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“…This active pharmaceutical ingredient (API) is hydrolyzed into the R2 form in the presence of water, and is also oxidized into the R5 form during preservation (Tomar R.S. et al, 2004;Bharathi Ch. et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

Photostability of Risperidone in Tablets

Fujisawa¹,

Takahashi²,

Teraoka

et al. 2018

KONA

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The purpose of this study is to evaluate the photostabilization mechanism of risperidone tablets. Risperidone is widely used for sensory integration disorder. It is formulated as tablets, orally disintegrating tablets, fine granules, oral solutions, and intramuscular injections. We found that risperidone was unstable in tablets and generated oxidized products. Formation of the oxidized product R5 was promoted in the presence of hydroxypropylcellulose by photoirradiation. On the other hand, photostability improved greatly when carmellose (CMC) or carmellose calcium (CMC-Ca) was used as a disintegrant. Since CMC and CMC-Ca are acidic substances, the photostability of tablets may have been affected by pH. Therefore, the effects of different pHs were examined. Risperidone was dissolved in methanol and the buffer (in the presence or absence of hydroxypropylcellulose) at different pHs (1.2, 3.0, 4.0, 5.0, and 6.8) was added. The photodegradation of risperidone was not observed at less than pH 3.0 in the presence of hydroxypropylcellulose, and low pHs improved the photostability of risperidone. On the other hand, risperidone solution without hydroxypropylcellulose was stable at all pH values. Therefore, risperidone was photochemically oxidized in the presence of hydroxypropylcellulose at high pHs.

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Identification, isolation and characterization of potential degradation product in risperidone tablets

Cited by 9 publications

References 10 publications

Pharmaceuticals and Related Drugs

Pharmaceuticals and Related Drugs

Application of the “Method Operable Design Region” (MODR) approach for the development of a UHPLC method for the assay and purity determination of risperidone in risperidone drug substance and other formulations

Photostability of Risperidone in Tablets

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