Validation of stability indicating RP-HPLC method for the estimation of mesalamine in bulk and tablet dosage form

Sahoo, Nalini Kanta; Sahu, Madhusmita; Rao, Podilapu Srinivasa; Ghosh, Goutam

doi:10.1016/j.phme.2013.12.003

Cited by 27 publications

(14 citation statements)

References 3 publications

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“…Establishment of an efficient bioanalytical method is highly useful for analysis of the drug molecules in rat and human plasma during pharmacokinetic, bioequivalence and toxicological studies. For estimation of nevirapine, several literature reports have been documented for chromatographic method analysis and quantification of nevirapine in biological samples employing high-performance liquid chromatography (Hamrapurkar et al, 2010;Nandi et al, 2012;Sahoo et al, 2013), and tandem mass liquid chromatography (LC-MS/MS; Chi et al, 2003;Hollanders et al, 2000;Marinho et al, 2014;Pav et al, 1999;van Heeswijk et al, 1998). These chromatographic methods are associated with several intricacies and inadequacies, like the use of high-cost solvents, buffers and guard columns, and the need for close monitoring of flow rate, injection volume, flow gradient, column oven temperature, pH, etc., which invariably are critical for consistent method performance during routine analysis (Burhenne, 2012;Tiwari and Tiwari, 2010).…”

Section: Introductionmentioning

confidence: 99%

QbD‐oriented development and validation of a bioanalytical method for nevirapine with enhanced liquid–liquid extraction and chromatographic separation

Beg

Chaudhary

Sharma

et al. 2015

Biomedical Chromatography

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The present studies describe the systematic quality by design (QbD)-oriented development and validation of a simple, rapid, sensitive and cost-effective reversed-phase HPLC bioanalytical method for nevirapine in rat plasma. Chromatographic separation was carried out on a C18 column using isocratic 68:9:23% v/v elution of methanol, acetonitrile and water (pH 3, adjusted by orthophosphoric acid) at a flow rate of 1.0 mL/min using UV detection at 230 nm. A Box-Behnken design was applied for chromatographic method optimization taking mobile phase ratio, pH and flow rate as the critical method parameters (CMPs) from screening studies. Peak area, retention time, theoretical plates and peak tailing were measured as the critical analytical attributes (CAAs). Further, the bioanalytical liquid-liquid extraction process was optimized using an optimal design by selecting extraction time, centrifugation speed and temperature as the CMPs for percentage recovery of nevirapine as the CAA. The search for an optimum chromatographic solution was conducted through numerical desirability function. Validation studies performed as per the US Food and Drug Administration requirements revealed results within the acceptance limit. In a nutshell, the studies successfully demonstrate the utility of analytical QbD approach for the rational development of a bioanalytical method with enhanced chromatographic separation and recovery of nevirapine in rat plasma. Copyright © 2015 John Wiley & Sons, Ltd.

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Section: Introductionmentioning

confidence: 99%

QbD‐oriented development and validation of a bioanalytical method for nevirapine with enhanced liquid–liquid extraction and chromatographic separation

Beg

Chaudhary

Sharma

et al. 2015

Biomedical Chromatography

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“…Then, samples were examined and photographed with Hitachi, TEM at 100 KV. [18] Photon correlation spectroscopy (PCS) and laser diffraction (LD) are the most powerful techniques for routine measurements of particle size. The Coulter method is rarely used to measure niosomes particle size because of difficulties in the assessment of small nanoparticle and the need of electrolytes which may destabilize colloidal dispersions.…”

Section: Morphological Analysis By Transmission Electron Microscopy (mentioning

confidence: 99%

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Shrivastava¹

2019

AJP

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Aim and Objective: Adapalene (ADP) is very effective in 0.01% strength, but it causes skin erythema in the applied area. ADP and benzoyl peroxide (BPO) are the most commonly used drugs in treatment of acne. ADP acts as keratolytic agent and BPO acts as potent antibacterial agent, both the drugs are used individually in a cyclic manner. The combination of both drugs if used judiciously can be used to cure mild to moderate acne effectively by acting on pathogenetic site. The successful treatment of acne depends on the maintenance of effective drug concentration levels at the affected site. The main benefit over liposome is that the lipids are replaced by non-ionic vesicles and hence the preparation is totally non-antigenic. Materials and Methods: The non-ionic surfactants like SPANs are obtained from synthetic sources, and hence the quality is maintained same all the time. The ADP was incorporated into niosomes using SPAN 60 and cholesterol was used as a stabilizer. Various ratios of SPAN 60, cholesterol, Stearic acid, BPO, and ADP were tried and optimized. Various process parameters were also optimized for the rotary flask evaporation method. The present study investigates the effect of niosomal coadministration of BPO and ADP in term of in vitro skin retention study and in vivo antiacne effects. These vesicular carriers, because of their improved percutaneous delivery and better skin retention, have proved to be very useful in enhancing therapeutic index of drugs used for tropical diseases. The niosomal dispersion was incorporated into Carbopol gel. The gel was kept for 3 months accelerated stability studies. Results and Discussion: The niosomal dispersion was evaluated for various parameters such as vesicle size, shape, and morphology by transmission electron microscopy. In vitro and in vivo studies were carried out. The drug release pattern from gel was evaluated on the basis of in vitro studies and skin irritation studies on rabbit skin. Conclusion: The in vitro study shows sustained release gel effects whereas the in vivo study shows no signs of irritation on the applied skin area.

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“…It makes available safeguard towards the perfection of colorectal most cancers in patient distress commencing inflammatory bowel disease. [1][2][3] The function of Mesalazine (MSZ) be to wedge the developed of prostaglandins and leukotrienes. It besides restrain of bacterial peptide-brought on, expected executioner portable bustle, inhibition of cyclo oxygenase and lipoxygenase alleyway and mutilation of neutrophil chemo taxis, adenosine-brought on emission.…”

Section: Introductionmentioning

confidence: 99%

Electrochemical Recognition and Electrochemical Oxidation of Mesalazine Drug at PMA Modified Glassy Carbon Electrode

Gupta¹,

Vallabhaneni²

2021

IJPI

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Background: Electrochemistry was the foremost subdivision of the chemistry its interred correlated to the entire other chemistries. Primarily it can settle on the nature of compound reactions by physically depends on the applying extent of electricity. The magnitude container is agreed away in connecting the optimistic and negative electrodes at the being there of analytic nearby in solution medium. Thus the electrochemistry is essentially depended on the reaction of chemical changes are by the persuade current of applying, on this perception the electricity is on the inside associated to the chemical type which are in attendance in the chemical compounds. These genus are sensitive to the functionalised electric value of potentials, and it was seen in varying of chemical reactions. In that basis, the changing of reactions is extensive in electrochemical reactions. Methods: In this Cyclic Voltammetry experimental method, crucial principal subsequent, instrumentation, and chemical changing noticing potentiostat of the electrochemical cell and recording apparatus are studied. The working electrodes are glassy carbon electrode was used for the harvest of this research work. How the glassy carbon electrode is useful to bring good results from using analytes. The procedures for doing a modification with modifiers on the surface of the electrode are clearly discussed. Results: A quick-tempered and miniature responsive analytical advance became evolved for the electrochemical oxidation of Mesalazine (MSZ) the procedure of electro ionic deposited modified PMA altered glassy carbon electrode (MGCE). The distorted electrode specify electrocatalytic attention in the bearing of the oxidation of MSZ drug in 0.2M phosphate buffer solution (PBS) of pH 7.4 with the assist of using cyclic voltammetric (CV) technique. The restrict of detection develop into calculated to be 79.50nM at misused electrode. The impacts of experiment charge observe shows evidence of an adsorption deal with electrode phenomenon. The altered electrode might be used as an analytical apparatus for the enthusiasm MSZ drug in pharmaceutical formulations. Conclusion: The planned electrode deposited PMA MGCE grows to be engaged for the electro-oxidation and stamina of an imperative drug MSZ at physiological pH by revenue of the use of CV modus operandi. The discovery perimeter grows to be calculated to be 79.50nM on behalf of MSZ with the method of CV.

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Validation of stability indicating RP-HPLC method for the estimation of mesalamine in bulk and tablet dosage form

Cited by 27 publications

References 3 publications

QbD‐oriented development and validation of a bioanalytical method for nevirapine with enhanced liquid–liquid extraction and chromatographic separation

QbD‐oriented development and validation of a bioanalytical method for nevirapine with enhanced liquid–liquid extraction and chromatographic separation

Untitled

Electrochemical Recognition and Electrochemical Oxidation of Mesalazine Drug at PMA Modified Glassy Carbon Electrode

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