Method development and Validation of RP-HPLC method for the Determination of Olanzapine in Bulk and Tablet Dosage form

Saibaba, S V; P, Shanmuga Pandiyan

doi:10.22159/ajpcr.2017.v10i5.17375

Cited by 5 publications

(2 citation statements)

References 6 publications

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“…Typically, HPLC techniques rely on a stationary phase that is hydrophobic in conjunction with the help of polar mobile phase to achieve effective separation [14][15][16] . Commonly utilized column types such as C18 and C8 facilitate the separation of various components within the sample, thereby expediting HPLC studies, streamlining the analysis process, and ultimately reducing costs [17][18][19][20] .…”

Section: Introductionmentioning

confidence: 99%

A novel Green systematic HPLC and UV-Spectroscopic method for the determination of rifaximin in tablet formulation

Bisoyi,

Pradhan,

Sahoo

et al. 2024

Preprint

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A sustainable approach has been devised for quantifying rifaximin in pharmaceutical products, utilizing both spectrophotometric and HPLC methods. In the spectrophotometric technique, accurate measurement of absorbance at 296 nm detection wavelength was conducted by taking water and acetonitrile (1:1) as the solvent. For the HPLC method, a phenomenonex C18 250 x 4.6mm,5µ column was employed, with water and acetonitrile (1:1 v/v) serving as the mobile phase. Isocratic separation elution technique was employed at a rate of 1 mL per minute, with detection of rifaximin at 296 nm. These methods were found to be cost-effective, quick, eco-friendly, and straight forward, giving an analysis of rifaximin in 20 minutes. Application of these methods to pharmaceutical products yielded results free from matrix interference, with statistical comparison showing no significant differences among the techniques. Furthermore, the assessment of greenness conducted using AGREE software highlighted the developed methods' is environmental friendliness, which rely on solvents such as acetonitrile and water. These findings advocate for the adoption of our both analyst- and environmentally-friendly methods for the determination of rifaximin in tablet formulation over presently employed techniques.

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Section: Introductionmentioning

confidence: 99%

A novel Green systematic HPLC and UV-Spectroscopic method for the determination of rifaximin in tablet formulation

Bisoyi,

Pradhan,

Sahoo

et al. 2024

Preprint

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“…The extent of degradation observed in stress conditions was higher than the accepted degradation level which necessitates the optimization of stress conditions. 15 In some of the reported research works, [16][17][18] attempts were made to develop an assay method for RFX. The study focussed on the estimation of the drug and was not extended to develop stability-indicating assay method (SIAM) and also no impurity profiling was performed.…”

Section: Introductionmentioning

confidence: 99%

Stability-Indicating Liquid Chromatography Method for Rifaximin and LC-MS Characterization of its Potential Degradants

Chaturvedi,

Chopra,

Desai

et al. 2023

IJPQA

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Rifaximin (RFX) is a structural analog of rifampin that has been shown to be a gastrointestinal-selective antibiotic with broad-spectrum antibacterial properties, a pronounced safety profile, and limited drug interactions. Crohn’s disease, diarrhea, hepatic encephalopathy, irritable bowel syndrome, and traveler’s diarrhea caused by non-invasive diarrheagenic Escherichia coli, can all be treated with rifaximin. FDA has designated RFX as an orphan drug for the treatment of hepatic encephalopathy. There is a substantial need for analytical quality monitoring of Rifaximin to ensure the safety and efficacy of treatment. To generate degradants, forced degradation study of the drug was carried out in acid, alkali, oxidative, thermal, and photolytic stress conditions. The optimum separation of the drug, and its degradants was achieved on an Inertsil ODS-3V C18 column (250 X 4.6 mm X 5 μm) under gradient elution conditions using, 10 mM potassium dihydrogen orthophosphate (pH 5.0 ± 0.05) as mobile phase A, and acetonitrile as mobile phase B, at a flow rate of 1.0 mL/min. The run time was 41 minutes and the detection wavelength was 258 nm. The method was validated in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use Guidelines. The drug was stable in neutral hydrolysis, photo and dry heat degradation conditions. The percentage degradation observed during acid, alkali hydrolysis and oxidative stress conditions were 70.46, 15.11 and 24.18, respectively. The degradants were investigated by LC-MS which indicated the presence of four (m/z 784.2, 744.5, 784.3, 753.8), three (m/z 744.5, 784.3, 753.8) and five (m/z 772.4, 838.4, 744.5, 753.8, and 801.9) degradants in acid, alkali and oxidative stress conditions, respectively. The structures of degradants were elucidated using Liquid chromatography–mass spectrometry (LC-MS) and Liquid chromatography tandem mass spectrometry (LC-MS/MS) analyses.

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Quality by design tool evaluated green stability-indicating UPLC content determination method for the Olanzapine and Samidorphan dosage form

Menda,

Chintala,

Kowtharapu

et al. 2024

Microchemical Journal

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Method development and Validation of RP-HPLC method for the Determination of Olanzapine in Bulk and Tablet Dosage form

Cited by 5 publications

References 6 publications

A novel Green systematic HPLC and UV-Spectroscopic method for the determination of rifaximin in tablet formulation

A novel Green systematic HPLC and UV-Spectroscopic method for the determination of rifaximin in tablet formulation

Stability-Indicating Liquid Chromatography Method for Rifaximin and LC-MS Characterization of its Potential Degradants

Quality by design tool evaluated green stability-indicating UPLC content determination method for the Olanzapine and Samidorphan dosage form

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