Evaluation of agomelatine stability under different stress conditions using an HPLC method with fluorescence detection: application to the analysis of tablets and human plasma

El-Shaheny, Rania

doi:10.1002/bio.2642

Cited by 20 publications

(11 citation statements)

References 7 publications

(20 reference statements)

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“…These obtained results are in accordance with the previous reports. [7,9] A proposed pathway for AGM acidic and alkaline degradation was provided ( Figure 7). …”

Section: Identification Of Acidic and Alkaline Induced Degradation mentioning

confidence: 99%

“…[2] It has proven to have anxiolytic properties and thus may prove to be very useful in the treatment of anxiety disorders. [3] The literature reveals that very few analytical methods have reported the estimation of AGM in different matrices including spectrophotometry [4] , high pressure liquid chromatography (HPLC) [4][5][6][7][8][9][10] and LC-MS. [11] None of the literature review indicates spectrofluorimetric methods for AGM. Therefore, an attempt has been made to develop spectrofluorimetric methods for AGM.…”

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confidence: 99%

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Application of quinone‐based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form: Identification of acidic and alkaline‐ induced degradation products by LC–MS/TOF

2017

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Three spectrofluorimetric methods were developed for agomelatine (AGM) determination in commercial tablets. Method A is based on measuring the native fluorescence of AGM aqueous solution at 230/360 nm. Methods B and C are based on the formation of a charge transfer complex between AGM and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) and 7,7,8,8- [1] It is a new melatonergic antidepressant with a structure closely related to melatonin. It plays a very important role in treating patients with major depressive disorder. AGM displays its action through combining melatonin (MT)1 and MT agonist properties with a serotonin 5-HT2C antagonist effect. [2] It has proven to have anxiolytic properties and thus may prove to be very useful in the treatment of anxiety disorders. [3] The literature reveals that very few analytical methods have reported the estimation of AGM in different matrices including spectrophotometry [4] , high pressure liquid chromatography (HPLC) [4][5][6][7][8][9][10] and LC-MS.[11]None of the literature review indicates spectrofluorimetric methods for AGM. Therefore, an attempt has been made to develop spectrofluorimetric methods for AGM. Recently, spectrofluorimetry has been widely applied in different fields of pharmaceutical analysis due to the high sensitivity and selectivity of the technique. Moreover, spectrofluorimetry has many merits over other different analytical techniques. Overall, its known to have inherent sensitivity, less time consumption and economical property on comparison with other techniques. Therefore, we were promoted to study the use of the native fluorescence of AGM and the fluorescence of charge transfer complexes between AGM and DDQ and TCNQ to develop highly sensitive fluorimetric methods for AGM analysis in bulk and dosage form. Ind. Co., were purchased from Egyptian pharmacies. | Material and reagents | Standard solutionsStock solutions (100 μg/ml) of AGM were prepared in Milli-Q water for method A and in methanol for methods B and C. To prepare working solutions, further dilution of the stock solutions was made with Milli-Q water or methanol. The solutions were stored at 4°C in a refrigerator and were stable for at least 7 days. | Stoichiometry of the reactionThe stoichiometry of the reaction was studied using Job's method of continuous variation. Reagent, respectively). The RFI of each solution was then measured at the specified excitation and emission wavelength against blank solution prepared simultaneously. The RFI values were plotted against the volume fraction of reagent. | Analysis of AGM in Inspago® tabletsFourteen tablets were weighed and mixed. A quantity of the powder equivalent to 50.0 mg of AGM was transferred into a 100 ml volumetric flask, completed to volume with Milli-Q water for method A and with acetonitrile for methods B and C, sonicated for 40 min and filtered, rejecting the first portion of the filtrate and then proceeding as in construction of calibration curves for all methods. The nominal contents of tablets were calculated by refer...

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“…These obtained results are in accordance with the previous reports. [7,9] A proposed pathway for AGM acidic and alkaline degradation was provided ( Figure 7). …”

Section: Identification Of Acidic and Alkaline Induced Degradation mentioning

confidence: 99%

mentioning

confidence: 99%

Application of quinone‐based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form: Identification of acidic and alkaline‐ induced degradation products by LC–MS/TOF

2017

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“…It is a selective agonist of the human melatonergic MT 1 and MT 2 receptors and also shows 5-HT 2C receptor antagonist activity. [3][4] Very few analytical methods have been reported for the determination of AGM such as HPLC, [5][6][7][8][9][10][11] LC-MS/MS in human plasma and HPTLC. 14 So, at present the authors have developed a stability indicating RP-HPLC method for the determination of AGM in presence of its degradation products.…”

Section: Introductionmentioning

confidence: 99%

A New Validated Stability Indicating Liquid Chromatographic Method for the Determination of Agomelatine

Annapurna¹,

Venkatesh²

2015

PHME

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Agomelatine is a melatonergic anti-depressant. A stability-indicating high performance liquid chromatographic technique was developed for the determination of Agomelatine in pharmaceutical formulations. Chromatographic separation was achieved on Shimadzu Model CBM-20A/20 Alite, using Zorbax extended-C 18 column (150 × 4.6 mm i.d., 5 µm particle size) with a mixture of 0.1% ammonium formate and acetonitrile (40:60, v/v) as mobile phase with a flow rate of 0.8 ml/min. Agomelatine was subjected to stress conditions such as acidic, alkaline, oxidation photolytic and thermal degradations and the method was validated as per ICH guidelines.

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“…A stability study ensures the maintenance of product quality, safety, and efficacy throughout its shelf life. Stress testing can help identify degradation products and provide important information about the intrinsic stability of drug substances [ 9 , 10 ]. Regulatory agencies recommend the use of stability-indicating assay methods for the analysis of stability samples [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Validation of a Stability-Indicating RP-HPLC Method for Determination of L-Carnitine in Tablets

Khoshkam

Afshar

2014

International Scholarly Research Notices

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A rapid and stability-indicating RP-HPLC method was developed for determination of l-carnitine in tablets. The separation was based on a C18 analytical column using a mobile phase which consisted of 0.05 M phosphate buffer (pH = 3): ethanol (99 : 1), including 0.56 mg/mL of sodium 1-heptanesulfonate. Column temperature was set at 50°C and quantitation was achieved by UV detection at 225 nm. In forced degradation studies, the drug was subjected to oxidation, hydrolysis, photolysis, and heat. Among the different stress conditions, the exposure to acidic and basic conditions was found to be an important adverse stability factor. The method was validated for specificity, selectivity, linearity, precision, accuracy, and robustness. The applied procedure was found to be linear in l-carnitine concentration range of 84.74–3389.50 µg/mL (r 2 = 0.9997). Precision was evaluated by replicate analysis in which relative standard deviation (RSD) values for areas were found below 2.0%. The recoveries obtained (100.83%–101.54%) ensured the accuracy of the developed method. The expanded uncertainty (3.14%) of the method was also estimated from method validation data. Accordingly, the proposed validated and rapid procedure was proved to be suitable for routine analyzing and stability studies of l-carnitine in tablets.

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Evaluation of agomelatine stability under different stress conditions using an HPLC method with fluorescence detection: application to the analysis of tablets and human plasma

Cited by 20 publications

References 7 publications

Application of quinone‐based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form: Identification of acidic and alkaline‐ induced degradation products by LC–MS/TOF

Application of quinone‐based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form: Identification of acidic and alkaline‐ induced degradation products by LC–MS/TOF

A New Validated Stability Indicating Liquid Chromatographic Method for the Determination of Agomelatine

Validation of a Stability-Indicating RP-HPLC Method for Determination of L-Carnitine in Tablets

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