A novel validated RP-HPLC-DAD method for the estimation of Eluxadoline in bulk and pharmaceutical dosage form

Panigrahy, Uttam Prasad; Reddy, A. Sunil Kumar

doi:10.5958/0974-360x.2015.00263.2

Cited by 18 publications

(15 citation statements)

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“…Sofosbuvir inhibits the RNA polymerase that the hepatitis C virus uses to replicate its RNA. The ledipasvir/sofosbuvir combination is a direct-acting antiviral agent that interferes with HCV replication and can be used to treat patients with genotypes 1a or 1b without PEGinterferon or ribavirin.The chemical structures of Sofosbuvir and Ledipasvir were represented in the figures 11 and 12 respectively [32,33].…”

Section: Ledipasivir and Sofosbuvirmentioning

confidence: 99%

Analytical Methods for the Recently Approved Fda New Molecular Entities – A Review

Archakam¹,

Chenchugari²,

Banoth³

2016

JCP

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Analytical method development and validation for the analysis therapeutic components and associated substances play an important role in the discovery, development and manufacture of pharmaceuticals and natural medicinal compounds. Pharmaceutical and herbal products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in a single dosage. The new chemical entities and combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products [1].Analytical method development and validation though often considered routine, too little attention is paid to them with regards for their potential to contribute to overall developmental time and cost efficiency. These method-related activities are interrelated. They are iterative, particularly during early drug development phases. Parts of each process may occur concurrently or be refined at various phases of drug development. Changes encountered during drug development may require modifications to existing analytical methods. These modifications may require additional validation or transfer activities. In this paper, the overview the

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Section: Ledipasivir and Sofosbuvirmentioning

confidence: 99%

Analytical Methods for the Recently Approved Fda New Molecular Entities – A Review

Archakam¹,

Chenchugari²,

Banoth³

2016

JCP

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“…Amlodipine is a calcium channel blocker and a synthetic dihydropyridine having antihypertensive and antianginal effects [1][2][3]. Amlodipine prevents vascular and cardiac contraction by inhibiting the inflow of extracellular calcium ions into myocardial and peripheral vascular smooth muscle cells [4][5][6]. Amlodipine (AMD) is a 2-[(2-Aminoethoxy) methyl] compound.…”

Section: Introductionmentioning

confidence: 99%

Qbd Based RP-HPLC Method Development and Validation for Simultaneous Estimation of Amlodipine Besylate and Lisinopril Dihydrate in Bulk and Pharmaceutical Dosage Form

Babar

Padwal

Bachute³

2021

JPRI

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The objective of this experiment was to develop and validate a simple, robust, and accurate QbD based Reverse-Phase High-Performance Liquid Chromatography method for Simultaneous estimation of Amlodipine besylate and Lisinopril dihydrate in bulk and Pharmaceutical Dosage form. A box-Behnken design was employed for optimizing the mobile phase, flow rate and pH of buffer, the optimized chromatographic conditions were Phosphate buffer: Methanol (25: 75 v/v), pH of buffer: 6.5 and flow rate: 1mL/min. Furthermore formulation injected and observed that the additives do not interfere with the peak of Amlodipine besylate and Lisinopril dehydrate. Both drugs are well resolved and Retention times were found to be 2.332 min and 3.584 min respectively. Linearity was observed in the concentration range of 10 μg to 50 μg/mL (r2=0.999). The accuracy range was 99.75 to 100.04%. Intra-day and Inter-day precision was found to be less than 2% RSD. The proposed method was useful for the best analysis of Amlodipine besylate and Lisinopril dihydrate in Bulk, pharmaceutical dosage forms and was successfully applied to routine analysis.

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“…In accordance to literature review, it was known that there were only few methods such as reverse-phase high-performance liquid chromatography (RP-HPLC) [9][10][11], ultraviolet (UV) spectroscopy [11], and liquid chromatography coupled with tandem mass spectrometry method [12][13][14] developed for the estimation of lenvatinib.…”

Section: Introductionmentioning

confidence: 99%

New Stability-Indicating Ultra Performance Liquid Chromatography Method Development and Validation of Lenvatinib Mesylate in Bulk Drug and Pharmaceutical Dosage Forms

Bandla¹,

Ganapaty

2018

Asian J Pharm Clin Res

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Objective: The objective of the present study was to develop and validate a new stability-indicating method for the quantification of lenvatinib mesylate in bulk drug and pharmaceutical dosage form using ultra performance liquid chromatography (UPLC).Methods: The optimized chromatographic conditions for elution of drug included UPLC HSS C18 (100 mm × 2.1 mm, 1.8 m) column, mixture of 0.1% orthophosphoric acid and acetonitrile (50:50 v/v%) mobile phase run on an isocratic mode at a flow rate of 0.3 mL/min, 240 nm detection wavelength, and column oven temperature maintained at 30°C.Results: The retention time for lenvatinib was found to be 1.24 min. The developed method was validated for various validation parameters in accordance with the International Conference on Harmonization guidelines. The method obeyed Beer’s law in the concentration range of 2.5– 15 μg/mL with a correlation coefficient of 0.9996. The percentage relative standard deviation and percentage recovery were determined to be 0.4 and 99.66–100.30%, respectively. The developed method was found to be accurate, precise, specific, linear, rugged, and robust. Forced degradation studies were conducted by exposing the drug to diverse stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was obtained within the limits.Conclusion: The developed method for the estimation of lenvatinib can be employed to routine analysis of pharmaceutical dosage form.

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A novel validated RP-HPLC-DAD method for the estimation of Eluxadoline in bulk and pharmaceutical dosage form

Cited by 18 publications

References 0 publications

Analytical Methods for the Recently Approved Fda New Molecular Entities – A Review

Analytical Methods for the Recently Approved Fda New Molecular Entities – A Review

Qbd Based RP-HPLC Method Development and Validation for Simultaneous Estimation of Amlodipine Besylate and Lisinopril Dihydrate in Bulk and Pharmaceutical Dosage Form

New Stability-Indicating Ultra Performance Liquid Chromatography Method Development and Validation of Lenvatinib Mesylate in Bulk Drug and Pharmaceutical Dosage Forms

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