A validated chiral liquid chromatographic method for the enantiomeric separation of Rivastigmine hydrogen tartarate, a cholinesterase inhibitor

Srinivasu, M.K.; Rao, B.M.; Reddy, B. Shyam Sundar; Kumar, Prathap; Chandrasekhar, K.B.; Mohakhud, P. K.

doi:10.1016/j.jpba.2004.12.023

Cited by 16 publications

(5 citation statements)

References 11 publications

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“…A literature survey revealed Liquid chromatographic-Tandem Mass spectrometry method for estimation of Rivatigmine and its major metabolite in human plasma and rat brain has been established 4,5 . Enantiomeric separation RVT has been studied 6 . Stability-indicating liquid-chromatographic method have been developed 7 , and identification and characterization of new impurities in RVT has been discussed 8 .…”

Section: Rivastigmine Hydrogen Tartrate (Rvt) (S)-n-ethyl-n-methyl-3[mentioning

confidence: 99%

Validated Thin-Layer Chromatography/Densitometry Method for the Analysis of Anti-Alzheimer Drug in Bulk and in Capsule Formulation

Khan

Shirkhedkar

2015

J. Chil. Chem. Soc.

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A simple, sensitive and precise Thin-Layer Chromatography (TLC)/ Densitometry method has been developed for estimation of Rivastigmine hydrogen tartrate [RVT] in bulk and in capsule formulation. The chromatographic separation was accomplished on aluminium backed precoated silica gel 60 F 254 as the stationary phase using n-Hexane: Ethyl acetate: triethylamine (1.5: 8.5: 0.3 v/v) as mobile phase. The R F value was observed to be 0.46 ± 0.02 for RVT when the sports were analyzed densitometrically at 213 nm. The method was linear in the range of 1000 -6000 ng band -1 with coefficient correlation value 0.9990. RVT was subjected to acid, alkali hydrolysis, oxidation, dry heat degradation and photo degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their R F values. Analysis of drug was performed in the presence of degraded samples. The proposed method validated for linearity, accuracy, precision and robustness. The developed TLC-densitometric method can be used as an alternative method for the precise assay of rivastigmine hydrogen tartrate in capsules form because it fulfils the validation criteria of an analytical method designated for quantity control of pharmaceutical preparations.

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Section: Rivastigmine Hydrogen Tartrate (Rvt) (S)-n-ethyl-n-methyl-3[mentioning

confidence: 99%

Validated Thin-Layer Chromatography/Densitometry Method for the Analysis of Anti-Alzheimer Drug in Bulk and in Capsule Formulation

Khan

Shirkhedkar

2015

J. Chil. Chem. Soc.

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“…The separation strategies are therefore valuable since they should propose a limited set of experimental conditions, which maximize the probability to separate numerous pharmaceuticals with different molecular structures and properties . Literature survey revealed that reported techniques for estimation of the drugs under investigation were HPLC, TLC, CE, and LC‐MS/MS …”

Section: Introductionmentioning

confidence: 99%

A chiral enantioseparation generic strategy for anti‐Alzheimer and antifungal drugs by short end injection capillary electrophoresis using an experimental design approach

2017

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The present study describes a generic strategy using capillary electrophoretic (CE) method for chiral enantioseparation of anti-Alzheimer drugs, namely, donepezil (DON), rivastigmine (RIV), and antifungal drugs, namely, ketoconazole (KET), Itraconazole (ITR), fluconazole (FLU), and sertaconazole (SRT) in which these drugs have different basic and acidic properties. Several modified cyclodextrins (CDs) were applied for enantioseparation of racemates such as highly sulfated α, γ CDs, hydroxyl propyl-β-CD, and Sulfobutyl ether-β-CD. The starting screening conditions consist of 50-mM phosphate-triethanolamine buffer at pH 2.5, an applied voltage of 15 kV, and a temperature of 25°C. The CE strategy implemented in the separation starts by screening prior to the optimization stage in which an experimental design is applied. The design of experiment (DOE) was based on a full factorial design of the crucial two factors (pH and %CD) at three levels, to make a total of nine (3 ) experiments with high, intermediate, and low values for both factors. Evaluation of the proposed strategy pointed out that best resolution was obtained at pH 2.5 for five racemates using low percentages of HS-γ-CD, while SBE-β-CD was the most successful chiral selector offering acceptable resolution for all the six racemates, with the best separation at low pH values and at higher %CD within 10-min runtime. Regression study showed that the linear model shows a significant lack of fit for all chiral selectors, anticipating that higher orders of the factors are most likely to be present in the equation with possible interactions.

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“…Recently, many chromatographic methods have been reported describing the use of chiral stationary phases in conjunction with HPLC, as ways to separate and thereby individually quantitate the enantiomers of an enantiomeric pair. 19,20 1.…”

Section: Introductionmentioning

confidence: 99%

Enantiomeric separation of sitagliptin by a validated chiral liquid chromatographic method

2014

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An enantioselective reversed phase high performance liquid chromatographic method was developed and validated. The enantiomers of sitagliptin were resolved on a Chiralcel OD-RH (150 mm Â 4.6 mm, 5 mm) column using a mobile phase system containing 3 M potassium di-hydrogen phosphate buffer (pH 4.0)methanol-acetonitrile (60 : 30 : 10, v/v/v). The resolution between the enantiomers was not less than 3.0. The pH value of buffer solution in the mobile phase played a key role in enhancing chromatographic efficiency and resolution between the enantiomers. The developed method was validated according to ICH guidelines. The calibration curve was found to be linear over the concentration range of 30-300 ng mL À1 (r 2 ¼ 0.9996). The limit of detection and limit of quantification of the (S)-enantiomer were found to be 8 and 30 ng mL À1 , respectively, for 20 mL injection volume. The percentage recovery of the (S)-enantiomer ranged from 99.06 to 100.2 in bulk drug samples of sitagliptin. The sample solution and mobile phase were found to be stable at least for 48 h. The final optimized method was successfully applied to separate the (S)-enantiomer from sitagliptin and was proved to be reproducible, accurate and robust for the quantitative determination of the (S)-enantiomer in bulk drugs.

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A validated chiral liquid chromatographic method for the enantiomeric separation of Rivastigmine hydrogen tartarate, a cholinesterase inhibitor

Cited by 16 publications

References 11 publications

Validated Thin-Layer Chromatography/Densitometry Method for the Analysis of Anti-Alzheimer Drug in Bulk and in Capsule Formulation

Validated Thin-Layer Chromatography/Densitometry Method for the Analysis of Anti-Alzheimer Drug in Bulk and in Capsule Formulation

A chiral enantioseparation generic strategy for anti‐Alzheimer and antifungal drugs by short end injection capillary electrophoresis using an experimental design approach

Enantiomeric separation of sitagliptin by a validated chiral liquid chromatographic method

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