Steroid Determination from Complex Mixtures by High Pressure Chromatographic Techniques

Landgraf, W.C.; Jennings, E.C.

doi:10.1002/jps.2600620221

Cited by 21 publications

(4 citation statements)

References 9 publications

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“…The molecular ion peak m/z value obtained for the degradation product resolving at 0.60 RRT is 454 [(MH)] + , in ESI positive mode corresponding to a molecular weights of 452. 5. C-NMR spectral data for fluocinonide and RRT ~0.60 is given in Table 3.…”

Section: Structure Elucidation Of Degradationmentioning

confidence: 99%

A Validated Stability-Indicating LC Method for Fluocinonide in the Presence of Degradation Products, Its Process-Related Impurities and Identification of Degradation Products

Srinivasu¹,

SubbaRao²,

Vegesna³

et al. 2010

AJAC

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The objective of the current study was to develop a validated, specific and stability-indicating reverse phase liquid chromatographic method for the quantitative determination of fluocinonide and its related substances. The determination was done for active pharmaceutical ingredient and its pharmaceutical dosage forms in the presence of degradation products, and its process-related impurities. The drug was subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis and thermal degradation per International Conference on Harmonization (ICH) prescribed stress conditions to show the stability-indicating power of the method. Significant degradation was observed during acid, base hydrolysis, and peroxide degradation. The major degradants were identified by LC-MS, FTIR and 1 H/ 13 C NMR spectral analysis. The chromatographic conditions were optimized using an impurity-spiked solution and the samples generated from forced degradation studies. In the developed HPLC method, the resolution between fluocinonide and its process-related impurities, (namely imp-1, imp-2, imp-3, imp-4, imp-5, imp-6, imp-7 and imp-8) and its degradation products was found to be greater than 2.0. The chromatographic separation was achieved on a C18, 250 mm × 4.6 mm, 5 µm column. The LC method employed a linear gradient elution and the detection wavelength was set at 240 nm. The stress samples were assayed against a qualified reference standard and the mass balance was found to be close to 99.3%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.

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Section: Structure Elucidation Of Degradationmentioning

confidence: 99%

A Validated Stability-Indicating LC Method for Fluocinonide in the Presence of Degradation Products, Its Process-Related Impurities and Identification of Degradation Products

Srinivasu¹,

SubbaRao²,

Vegesna³

et al. 2010

AJAC

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“…HPLC methods for corticosteroids in topical preparations such as creams, lotions, and ointments (5,6,(10)(11)(12)(13)(14)16,19,21, 22,(25)(26)(27)(28) 30) are particularly useful because of the complex nature of the sample matrix and the potential for interference in colorimetric or UV methods. Cortisone acetate, hydrocortisone acetate, and prednisolone acetate were separated on the same reversed-phase column using acetonitrile-water.…”

mentioning

confidence: 99%

“…HPLC methods for corticosteroids in topical preparations such as creams, lotions, and ointments (5,6,(10)(11)(12)(13)(14)16,19,21, 22,(25)(26)(27)(28) 30) are particularly useful because of the complex nature of the sample matrix and the potential for interference in colorimetric or UV methods. HPLC methods for corticosteroids in topical preparations such as creams, lotions, and ointments (5,6,(10)(11)(12)(13)(14)16,19,21, 22,(25)(26)(27)(28) 30) are particularly useful because of the complex nature of the sample matrix and the potential for interference in colorimetric or UV methods.…”

mentioning

confidence: 99%

High-Pressure Liquid Chromatographic Determination of Corticosteroids in Topical Pharmaceuticals

Williamsx¹,

Biehl

1981

Journal of Pharmaceutical Sciences

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“…Only recently have better methods of analysis (from a stability point of view) become available (9,10). The purpose of this study was to evaluate the effect of various vehicles and other active ingredients (iodochlorhydroxyquin, menthol, and phenol) on the stability of hydrocortisone.…”

mentioning

confidence: 99%

Effect of Vehicles and Other Active Ingredients on Stability of Hydrocortisone

Gupta

1978

Journal of Pharmaceutical Sciences

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Steroid Determination from Complex Mixtures by High Pressure Chromatographic Techniques

Cited by 21 publications

References 9 publications

A Validated Stability-Indicating LC Method for Fluocinonide in the Presence of Degradation Products, Its Process-Related Impurities and Identification of Degradation Products

A Validated Stability-Indicating LC Method for Fluocinonide in the Presence of Degradation Products, Its Process-Related Impurities and Identification of Degradation Products

High-Pressure Liquid Chromatographic Determination of Corticosteroids in Topical Pharmaceuticals

Effect of Vehicles and Other Active Ingredients on Stability of Hydrocortisone

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