Validated LC–MS/MS methods for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in human plasma and urine

Meulder, Marc De; Remmerie, Bart; Vries, Ronald de; Sips, Luc; Boom, S; Hooijschuur, Edwin W. J.; Merbel, Nico C. van de; Timmerman, Philip

doi:10.1016/j.jchromb.2008.04.041

Cited by 68 publications

(55 citation statements)

References 12 publications

(19 reference statements)

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“…Previous studies have described the analysis of risperidone and 9-hydroxy-risperidone in plasma, urine and serum using LC, LC/MS-MS and MEPS-LC-UV [17][18][19]. Locatelli et al [20] proposed the determination of these substances in biological fluids using HPLC methods, allowing for the simultaneous analysis of enantiomers.…”

Section: ) (Rs)-3-[2-[4-(6-fluorobenzo[d]mentioning

confidence: 99%

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Barbosa

Mantovani

Garcia

et al. 2012

ISRN Chromatography

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A stability-indicating liquid chromatographic (LC) method was studied for the determination of paliperidone in osmoticcontrolled release oral delivery system (OROS) tablets. A tablet extraction procedure was developed by testing the efficiency of solvents (water, HCl, NaOH, acetonitrile, methanol) and techniques (ultrasonic bath, magnetic stirrer), and evaluating the release of the drug with respect to time. A forced degradation study was conducted to demonstrate the stability-indicating power of the method. Chromatographic separation was achieved using an isocratic elution in a reversed-phase system with a mobile phase prepared from a mixture of phosphate buffer and acetonitrile. The use of an ultrasonic bath demonstrated paliperidone release from OROS tablets in a total time of 60 min. Verifying the efficiency of the chromatographic procedure, the theoretical plates (N = 12634.21) and tailing factor (tf = 1.31) were constant during repeated injections. The retention time of paliperidone was 4.8 min, and the method was validated within the concentration range of 10-50 µg mL −1 (r = 0.9999). Adequate reproducibility (RSD% = 0.30-0.59), interday precision (RSD% = 1.81), and accuracy were obtained. The proposed method was successfully applied to paliperidone determination in the presence of degradation products, and an efficient extraction procedure from the OROS tablets was developed.

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Section: ) (Rs)-3-[2-[4-(6-fluorobenzo[d]mentioning

confidence: 99%

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Barbosa

Mantovani

Garcia

et al. 2012

ISRN Chromatography

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show abstract

“…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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“…The chemical structure of the drug is presented in Figure 1. An extensive literature survey is carried out and found some LC-MS/MS methods [7][8] , HPTLC methods 9-10 , HPLC method 11 and a UPLC method 12 for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in plasma, urine pharmaceutical formulations respectively. …”

Section: Introductionmentioning

confidence: 99%

A Reverse Phase HPLC Method Development and Validation for the Determination of Paliperidone in Pure and Dosage Forms

UMAMAHESSWAR¹,

Ramu²,

Rambabu³

2012

Chem Sci Trans

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A simple reverse phase HPLC method was developed and validated for the assay of paliperidone in pure and tablets. The analysis was carried out on Shimadzu HPLC model equipped with inertsil ODS C-18 column, LC-10AT pump, variable wavelength programmable UV-Detector SPD-10AVP and rheodyne injector with 20µL fixed loop. Acetonitrile and methanol in the ratio 10:90 v/v at a flow rate of 1.0 mL/min was employed for elution and the components were detected at 235 nm at ambient temperature. The method was validated as per the ICH guidelines. The retention time for paliperidone was found to be 5.67 min. Linearity was observed in the concentration range of 20-120 ppm with correlation coefficient 0.9990. The percent of relative standard deviation of six replicate measurements was found to be 1.25 indicate that the proposed method was precise. Recovery studies were conducted at three different concentration levels within the linearity limits and the average percent of recovery was 99.56. The amount of paliperidone drug content present in tablet dosage form was determined and found to be 99.80%. Therefore, the developed method was simple, precise and accurate and can be successfully applied for the estimation of paliperidone in pharmaceutical dosage forms

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Validated LC–MS/MS methods for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in human plasma and urine

Cited by 68 publications

References 12 publications

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

Spectrophotometric Methods for the Quantitative Estimation of Paliperidone in Formulations

A Reverse Phase HPLC Method Development and Validation for the Determination of Paliperidone in Pure and Dosage Forms

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