Quantitative Determination of Paliperidone in OROS&amp;#174; Tablets by Derivative Spectrophotometric Method - Application in Extraction and Comparison to HPLC

Mendez, Andreas Sebastian Loureiro; Cassol, José Pedro Etchepare; Camargo, Vanessa Brum De; Malesuik, Marcelo Donadel; Garcia, Cássia Virgínia

doi:10.2174/15734110113099990039

Cited by 3 publications

(4 citation statements)

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“…To start the stability protocols, we performed an extraction procedure from osmotic tablets, using conditions defined in previous works (Barbosa et al, ; Mendez et al, ). An ultrasonic bath and acid solution (HCl 0.01 mol/L) have been established as adequate conditions for drug extraction from that compartment.…”

Section: Resultsmentioning

confidence: 99%

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Stability, degradation impurities and decomposition kinetics for paliperidone from osmotic tablets

Cassol

Barbosa

Garcia

et al. 2018

Biomedical Chromatography

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The antipsychotic paliperidone was investigated with a focus on stability, degradation impurities and kinetics reaction profile. Osmotic tablets 3 mg (OROS ) were subjected to extraction in an ultrasonic bath and the resulting acidic solution was stressed by forced conditions. Degraded samples were monitored by HPLC-DAD in different storage times for acidic and alkaline hydrolysis, oxidation, heat and photolysis. Photolysis was shown to be a strong degradation factor, with a drug content of 24.64% remaining after 24 h. Oxidation (H O 18%) caused a slow decomposition, with a drug content of 83.49% remaining after 72 h. Through kinetics graphics, first-order reactions were found for oxidation, heat and photolysis. By UPLC-MS analysis, the degraded matrix could be investigated for identification of impurities with m/z 445.3128, m/z 380.8906, m/z 364.9391, m/z 232.9832 and m/z 217.0076, allowing the identification of derivatives N-oxide and with modifications in the lactam, benzisoxazole and pyrimidine rings. Paliperidone in liquid state, like analytical solutions or formulation, must be carefully handled to avoid drug exposure, specially in storage conditions.

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Section: Resultsmentioning

confidence: 99%

“…For sample solution, paliperidone was previously submitted to extraction through an ultrasonic bath (Barbosa et al, ; Mendez, Cassol, De Camargo, Malesuik, & Garcia, ). Two OROS ® tablets (3 mg) were added to a 50 mL volumetric flask containing HCl 0.01 mol/L, then subjected to extraction for 60 min (paliperidone concentration = 120 μg/mL).…”

Section: Methodsmentioning

confidence: 99%

Stability, degradation impurities and decomposition kinetics for paliperidone from osmotic tablets

Cassol

Barbosa

Garcia

et al. 2018

Biomedical Chromatography

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“…This technique is highlighted in the scientific literature, in which several reports are focused in drug quantitation with a performance equivalent to HPLC, i.e. assaying fluoxetine (15), sulfasalazine (16), paliperidone (17) and posaconazole (18). In these studies, there is no significant difference between the results obtained by both techniques.…”

Section: Resultsmentioning

confidence: 99%

Uv Spectrophotometric Method for Quantitative Determination of Agomelatine in Coated Tablets

Barbosa¹,

Rodrigues²,

Volpato³

et al. 2017

Drug Anal. Res.

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UV spectrophotometry is an analytical technique used routinely for qualitative and quantitative assay due the low cost and reliability during analysis. In this work, it was validated a quantitative UV method for determination of agomelatine in coated tablets. The parameters specificity, linearity, precision, accuracy and robustness were evaluated according to official guidelines. Methanol was selected as solvent and the maximum wavelength for drug analysis was 230 nm. The purposed assay showed to be specific and the linearity was proved in a range of 0.5 - 2.5 µg/mL. The RSD values obtained during precision assay (inter-day RSD = 1.75%) indicated the method reproducibility, and the accuracy testing showed good results from recovery test. Robustness assay was complementary and showed that the purposed method is adequate for drug quantitation in commercial samples, being a reliable alternative to chromatographic assay.

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“…Official monographs for SMZ-TMP quantification in pharmaceutical preparation have been described using high performance liquid chromatography (HPLC) and spectrophotometric methods, which involve pre-separation of the analytes under investigation (2,3). Several other methods have also been reported for SMZ-TMP determination based on: (a) complexation reactions/spectrophotometric analysis (4), first derivative spectrophotometric analysis (5), bivariate calibration (6) and multivariate calibration (7-9).These alternative methods could replace those based on HPLC since they are faster and comparatively inexpensive (10)(11)(12)(13)(14). Nevertheless, alternative methods using ultraviolet (UV) spectrophotometric techniques require multivariate data processing due to spectral overlap and pH adjustment due to a shift in the lambda maximum.…”

Section: Introductionmentioning

confidence: 99%

The effect of pH on the simultaneous determination of Sulfamethoxazole and Trimethoprim by Ultraviolet Spectrophotometry and Multivariate Calibration

Silva¹,

Almeida²,

Paula³

et al. 2017

Drug Anal. Res.

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Analytical techniques based on Ultraviolet (UV) spectrophotometry are widely used in pharmaceutical analysis, because they are simple and inexpensive. The choice of pH is critical in the development of univariate methods for pharmaceutical quantitation by UV spectrophotometry since changes may modify the absorption spectrum profile. Similar to univariate methods by UV spectrophotometry changes in pH may influence the predictive ability of multivariate models, affecting the resultant analytical performance. We report herein on the influence of pH on the simultaneous determination of sulfamethoxazole (SMZ) and trimethoprim (TMP) in tablets using UV spectrophotometry and multivariate calibration. Data were recorded using a UV spectrophotometer in the wavelength range of 200 to 350 nm. The experimental matrix was constructed using 36 synthetic samples of SMZ-TMP mixtures. The concentration ranges used for the investigation were 14.0 to 26.0 mg L-1 for SMZ and 2.8 to 5.2 mg L-1 for TMP. The Partial Least Squares (PLS) regression models were generated with full-spectrum and multiple pH levels. At pH 4.3, lower values of relative standard error of prediction (RSEP %) for SMZ (1.83) and TMP (1.13) were obtained. The PLS model at pH 4.3 was used for the quantification of real samples (tablets obtained from 13 different manufacturers) and the results were compared with conventional procedures using high performance liquid chromatography (HPLC).

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Quantitative Determination of Paliperidone in OROS® Tablets by Derivative Spectrophotometric Method - Application in Extraction and Comparison to HPLC

Cited by 3 publications

References 0 publications

Stability, degradation impurities and decomposition kinetics for paliperidone from osmotic tablets

Stability, degradation impurities and decomposition kinetics for paliperidone from osmotic tablets

Uv Spectrophotometric Method for Quantitative Determination of Agomelatine in Coated Tablets

The effect of pH on the simultaneous determination of Sulfamethoxazole and Trimethoprim by Ultraviolet Spectrophotometry and Multivariate Calibration

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