Kinetics and Factors Affecting Stability of Methylprednisolone in Aqueous Formulation

Amin, Mostafa Ibrahim; Bryan, Jon

doi:10.1002/jps.2600621106

Cited by 16 publications

(4 citation statements)

References 8 publications

(2 reference statements)

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“…It was clear that lisinopril-2H 2 O in aqueous media was rapidly degraded when compared with that in solid forms Table 6. It is a straight forward observation, as it is a well known fact that chemistry in the aqueous state is more rapid reaction than that in the solid form [14]. The stability of the lisinopril dihydrate solution UV decomposed was tested by placed sample under UV light at 254 nm for interval times.…”

Section: Resultsmentioning

confidence: 99%

Stress Degradation Studies on Lisinopril Dihydrate Using Modified Reverse Phase High Performance Liquid Chromatography

Adam¹

2014

AJAC

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A simple, precise, accurate and sensitive reverse phase high performance liquid chromatographic method for simultaneous estimation of lisinopril dihydrate and its degradation products occuring under different ICH prescribed stress conditions has been modified. Drug was resolved on a C18 column, utilizing modified mobile phase of tetra butyl ammonium hydroxide solution and acetonitrile. Ultra violet detection was carried out at 210 nm. The method was modified with respect to linearity, precision, accuracy, selectivity, specificity and ruggedness. The results obtained revealed that lisinopril dihydrate was an active product slightly changed under stress conditions.

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Section: Resultsmentioning

confidence: 99%

Stress Degradation Studies on Lisinopril Dihydrate Using Modified Reverse Phase High Performance Liquid Chromatography

Adam¹

2014

AJAC

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“…Samples were taken at 30, 60, 90, 120, and 150 minutes and tested for degradation by HPLC (Table 3 and Figures 6 and 7). reference standard was appear in Figures 2 and 3, it was found that cefixime trihydrate separation at 9.75 minute by using method 2 while separation at 13.03 minute by using method 1 [6][7][8][9]. Discrimination developed validated method 2 versus method 1 illustrated that from the assay test, the retention time of CEF-3H 2 O less than that time obtained by method 1 were 9.75, 13.03 minutes respectively (Table 1 and Figure 4).…”

Section: Preparation Of Degradation Product Of Cefiximementioning

confidence: 97%

Comparative Study for the Analysis of Cefixime Trihydrate and its Degraded Products by Two RP-HPLC Methods, One its Official and Other Developed Validated Method

Hk¹,

Mb²

2017

Mod Chem Appl

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The aim of the present work was aimed to carry out comparative study between method (1) and method (2) for separation of cefixime trihydrate and its degraded products by using two different mobile phases, keeping the other parameters such as stationary phase, column condition, wavelength, and device. Mobile phase for method (1) consist of a solution of 0.03 M Tetra butyl ammonium hydroxide (pH 6.5) and acetonitrile with a ratio of 3:1 respectively while Mobile phase for method (2) consist of a mixture of 0.1 M sodium dihydrogen phosphate monohydrate solution (pH 2.5) and methanol with a ratio 3:1 respectively. To study the degraded products sample was subjected to Sun light, UV light, and thermal effects. From data obtained proved the method (2) gave less retention time for the separation of drug with a larger number of decomposed products being detected compared by method (1).

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“…[11][12][13] Although a number of studies of the physical and chemical stabilities of MPNaS have been reported, [14][15][16][17][18][19] no published information is available on its stability in a dual chamber vial. [11][12][13] Although a number of studies of the physical and chemical stabilities of MPNaS have been reported, [14][15][16][17][18][19] no published information is available on its stability in a dual chamber vial.…”

Section: Copyright (Cc) Scsmentioning

confidence: 99%

Methylprednisolone and its related substances in freeze dried powders for injections

Solomun¹,

Ibrić²,

Vajs³

et al. 2010

JSCS

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In this work, the behavior of the active pharmaceutical substances methylprednisolone (in a form of methylprednisolone sodium succinate) in finished pharmaceutical dosage form, i.e., freeze-dried powder for injections, was examined. The goal was to evaluate the chemical stabilities of methylprednisolone sodium succinate packaged in a dual chamber vial, as a specific container closure system. The effect of different parameters: temperature, moisture and light were monitored. The method proposed by United States Pharmacopeia was used to determine concentrations of methylprednisolone, as the sum of the concentration of methylprednisolone esters (17-hydrogen succinate and 21-hydrogen succinate) and free methylprednisolone. The HPLC method was used for stability evaluation of the active substance and determination of related substances. Four main degradation products were registered. Temperature has a major impact on the degradation process with the appearance of 3 degradation products (impurities B, C and D), while the presence of light caused an increasing content of impurity A. Identification of impurity B, C and D has been realized using mass and NMR spectroscopy. All three substances are substances related to methylprednisolone.

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Kinetics and Factors Affecting Stability of Methylprednisolone in Aqueous Formulation

Cited by 16 publications

References 8 publications

Stress Degradation Studies on Lisinopril Dihydrate Using Modified Reverse Phase High Performance Liquid Chromatography

Stress Degradation Studies on Lisinopril Dihydrate Using Modified Reverse Phase High Performance Liquid Chromatography

Comparative Study for the Analysis of Cefixime Trihydrate and its Degraded Products by Two RP-HPLC Methods, One its Official and Other Developed Validated Method

Methylprednisolone and its related substances in freeze dried powders for injections

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