Rapid and selective UV spectrophotometric and RP-HPLC methods for dissolution studies of oxybutynin immediate-release and controlled-release formulations

Varma, Manthena V.; Kaushal, Aditya Mohan; Garg, Sanjay

doi:10.1016/j.jpba.2004.07.044

Cited by 14 publications

(6 citation statements)

References 15 publications

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“…The characteristics of the calibration curves are summarized in Table VI. Under the experimental conditions, the limit of detection (LOD) and the limit of quantification (LOQ) were calculated using LOD=3s/m and LOQ=10s/m (Varma, Kaushal, Garg, 2004) to evaluate the sensitivity of the proposed methods.…”

Section: Optimization Of the Chromatographic Conditionsmentioning

confidence: 99%

Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products

Sevim

Erk

2015

Braz. J. Pharm. Sci.

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The antiparkinson agent pramipexole dihydrochloride monohydrate was quantified in pharmaceutical products by high performance liquid chromatography (HPLC) and derivative spectrophotometry. The first method was based on HPLC using tamsulosin HCl as an internal standard. In this method, chromatographic separation was achieved using a LiChrospher 60 RP column at 25°C, with a flow rate of 1.0 mL/min at 263 nm. The eluent comprised 0.01 mol/L ammonium acetate (pH 4.4) and acetonitrile (35:65 by volume). The linearity range was found to be 10.0-30.0 µg/mL with a mean recovery of 100.5 ± 1.10. The limit of detection (8 ng/mL) and limit of quantification (50 ng/mL) were calculated. In the second method, the first derivative spectrophotometric technique for the determination of pramipexole dihydrochloride monohydrate was performed by measuring the amplitude at 249 and 280 nm. In the first derivative technique, the absorbance and concentration plot was rectilinear over the 5.0-35.0 µg/mL range with a lower detection limit of 1.5 ng/mL and quantification limit of 4.5 ng/mL. The typical excipients included in the pharmaceutical product do not interfere with the selectivity of either method. The developed methods were validated for robustness, selectivity, specificity, linearity, precision, and accuracy as per the ICH and FDA guidelines (ICH Q2B, 1996; FDA,2000). In conclusion, the developed methods were successful in determining the quantity of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products. The RSD values for the pharmaceutical product used in this study were found to be 0.97% for the HPLC method and 0.00% for the first derivative spectrophotometric method. O fármaco antiparkinsoniano, dicloridrato de pramipexol monoidratado, foi quantificado no produto farmacêutico por cromatografia líquida de alta eficiência (CLAE) e espectrofotometria derivada. No primeiro método baseado na CLAE, o cloridrato de tansulosina foi usado como padrão interno. Nesse método, a separação cromatográfica foi realizada usando uma coluna Lichrosper 60 RP a 25 °C e acetato de amônio 0,01 mol/L (pH:4.4): acetonitrila (35:65 em volume) como eluente com fluxo de 1,0 mL /min a 263 nm. A faixa de linearidade foi de 10.0-30.0 µg/mL com média da recuperação 100.5 ± 1.10. O limite de detecção (8 ng/mL) e o limite de quantificação (50 ng/mL) foram calculados. Por outro lado, a primeira técnica de espectrofotometria derivada para a determinação de dicloridrato de pramipexol monoidratado foi realizada através da medida da amplitude a 249 e 280 nm. Na técnia da primeira derivada, a absorvância e a plotagem da concentração foi retilínea na faixa de 5.0-35.0 µg/mL com limite inferior de detecção de 1.5 ng/mL e limite de quantificação de 4.5 ng/mL. Os excipientes típicos incluídos no produto farmacêutico não interferem com a seletividade dos métodos. Os métodos desenvolvidos foram validados quanto à robustez, seletividade, especificidade, linearidade, precisão e S. Sevim, N. Erk 880 exatidão de acordo com as diretrizes d...

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Section: Optimization Of the Chromatographic Conditionsmentioning

confidence: 99%

Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products

Sevim

Erk

2015

Braz. J. Pharm. Sci.

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“…1a) an anticholinergic agents is a tertiary amine that mainly acts as a direct smooth muscle relaxant and displays weak antimuscarinic activity [5,6]. A survey of the literature revealed that few methods have been reported for the determination of OXB such as UV and visible spectrophotometry [7][8][9], voltammetric [10], HPLC methods [11][12][13][14], gas chromatography in serum [15], Polymeric matrix membrane sensors were used for stability-indicating potentiometric determination of OXB and differential pulse polarography [16].…”

Section: Introductionmentioning

confidence: 99%

Extractive-Spectrophotometric Determination of Some Antimuscarinic Antagonist in Tablet Formulations Using Eriochrome Cyanine R

El‐Didamony

Saad

Saleem

2018

Int J Pharm Pharm Sci

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Objective: To develop and validate simple, rapid and sensitive spectrophotometric method for the assay of four antimuscarinic antagonists, namely oxybutynin (OXB), solifenacin (SOL), tolterodine (TOL) and fesoterodine (FES) in bulk and pharmaceutical formulations.Methods: The proposed method is based on the reaction of the selected drugs with eriochrome cyanine R (ECR) in buffered aqueous solution at pH 1.0. The formed ion-pair complexes were extracted with dichloromethane and measured quantitatively with maximum absorption at 464 nm. All variables that affect on color intensity such as pH, buffer volume and concentration of ECR and extractive solvents were studied and optimized.Results: The calibration graphs were linear over the concentration range of 4–24, 4–32, 4–32 and 2–22 mg/ml for OXB, SOL, TOL and FES, respectively. The stoichiometry of the reaction was found to be 1:1 in all cases. Molar absorptivity values were found to be 2.043×104, 1.856×104, 1.798×104 and 2.856×104 l/mol/cm for OXB, SOL, TOL and FES, respectively. Excipients which used as an additive in commercial formulations did not interfere in the analysis.Conclusion: The developed method was successfully applied to determine OXB, SOL, TOL and FES in pharmaceutical preparations. The developed method can be used for quality control and routine analysis where time, cost effectiveness and high specificity of analytical technique are of great importance.

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“…Hence, alternative methods for the analysis of oxybutynin have also been developed. 8 This suggests that the chromophore of oxybutynin is poor, in addition oxybutynin is a poor candidate for UV-Visible detection for its quantication at sub-microgram concentrations. Hence, it is necessary to use the other physicochemical properties of oxybutynin and advanced instrumentation, such as hyphenated techniques like GC-MS [9][10][11] or LC-MS, for detection purposes.…”

Section: Introductionmentioning

confidence: 99%

Electron capture detection of oxybutynin in plasma: precolumn derivatization approach and application to a pharmacokinetic study

Khire

Vavia

2014

Anal. Methods

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Oxybutynin is an antimuscarinic agent used for the treatment of an overactive bladder. Because of its poor chromophore, it is difficult to determine oxybutynin by HPLC-UV analysis The difficulty increases when the analysis involves a complex biological matrix like plasma. Precolumn derivatization with trifluoroacetic anhydride followed by GC separation and ECD was used to solve this problem. The developed GC-ECD method had good linearity in the concentration range 2-20 ng ml À1 with a correlation coefficient of 0.9959. The accuracy and sensitivity for the determination of the halogenated derivative by this method was better than that for GC-MS. NMR and mass spectroscopy data confirmed the derivatization reaction.The developed GC-ECD method was used to study the pharmacokinetic parameters of an oxybutynin transdermal patch (36 mg/39 cm 2 ) and oxybutynin gel (10% w/w). The C max , T max and AUC 0-96 values for the oxybutynin transdermal patch and oxybutynin gel were equivalent. Fig. 1 Chemical structure of oxybutynin and trifluoroacyl oxybutynin (TFA-OXB).

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Rapid and selective UV spectrophotometric and RP-HPLC methods for dissolution studies of oxybutynin immediate-release and controlled-release formulations

Cited by 14 publications

References 15 publications

Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products

Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products

Extractive-Spectrophotometric Determination of Some Antimuscarinic Antagonist in Tablet Formulations Using Eriochrome Cyanine R

Electron capture detection of oxybutynin in plasma: precolumn derivatization approach and application to a pharmacokinetic study

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