Selection of high-performance liquid chromatographic methods in pharmaceutical analysis

Szepesi, G.; Gazdag, M.; Mihályfi, K.

doi:10.1016/s0021-9673(00)94245-6

Cited by 56 publications

(30 citation statements)

References 14 publications

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“…An oxidative degradation product 243,251 and synthesis-related impurities were identified and quantificated by NP-HPLC, 132 NP-ion-pairing HPLC 257 and the oxidative degradant also by quantitative NMR spectroscopic measurement.…”

Section: Electroanalytical Methodsmentioning

confidence: 99%

“…), 107,108 betamethasone-diclofenac sodium-cyanocobalamine tablet, 109 ethinylestradiol-norgestrel tablet, 114 ethinylestradiollevonorgestrel and ethinylestradiol-gestodene tablets, 117 finasteride tablet (St), 118 fluocortolone pivalate and hexanoate suppositories, 119 hydrocortisone-oxytetracycline-nystatin in pharmaceutical preparations, 120 hydrocortisone acetate and hemisuccinate-lidocaine in pharmaceutical preparations, 121 hydrocortisone acetate-methyl-and propylparaben topical cream (St), 122 hydrocortisone sodium phosphate gel (St), 123 nestorone implants (St), 124 pancuronium bromide injection (St), 125 prednisolone acetate-tetrahydrozoline hydrochlorideofloxacin ophthalmic preparations, 126 prednisolone sodium phosphate implantable infusion pump (St), 127 progesterone in micellar systems and other formulations, 128 triamcinolone, its acetate and acetonide and several other corticosteroids (St), 129 triamcinolone acetonide dermatological patches, 130 triamcinolone acetonide, methyl-and propylparaben topical cream (St). 131 Carefully validated stability-indicating HPLC methods were used for the determination of impurities and degradants in bulk pipecuronium bromide, 132 budesonide, 133 aqueous spironolactone-β-cyclodextrin solutions, 134 and for the photodegradation kinetic study of danazol. 135 HPLC is eminently suitable for screening purposes, e.g.…”

Section: ·4 High-performance Liquid Chromatography (Hplc) Andmentioning

confidence: 99%

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Recent Advances in the Analysis of Steroid Hormones and Related Drugs

Gǒrög¹

2004

ANAL. SCI.

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Section: Electroanalytical Methodsmentioning

confidence: 99%

Section: ·4 High-performance Liquid Chromatography (Hplc) Andmentioning

confidence: 99%

Recent Advances in the Analysis of Steroid Hormones and Related Drugs

Gǒrög¹

2004

ANAL. SCI.

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“…The generally recommended degradation varies between 5-20% degradation. [24,25] Some conditions mostly used for forced degradation studies are presented in Table1. [26,27] www.wjpps.com …”

Section: Degradation Conditionsmentioning

confidence: 99%

An Updated Review: Forced Degradation Study

Srivastavá¹

2017

WJPPS

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Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop the stability indicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. The study ensures the appropriate stability of final pharmaceutical products in very early stages of pharmaceutical development. The forced degradation study is an essential step in the design of a regulatory compliant stability program for drug and formalized as a regulatory requirement. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms and also describes the analytical methods helpful for the development of stability indicating method.

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“…In general, values anywhere between 5% to 20% degradation of the drug substance have been considered as reasonable and acceptable for validation of chromatographic assays 37,38 .…”

Section: How Much Is Enoughmentioning

confidence: 99%

Untitled

2012

IJPSR

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High performance liquid chromatography is one of the most accurate methods widely used for the quantitative as well as qualitative analysis of drug product and is used for determining drug product stability. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacture of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. A number of key chromatographic factors were evaluated in order to optimize the detection of all potentially relevant degradants. The method should be carefully examined for its ability to distinguish the primary drug components from the impurities. New chemical entities and drug products must undergo forced degradation studies which would be helpful in developing and demonstrating the specificity of such stability indicating methods. At every stage of drug development practical recommendations are provided which will help to avoid failures. INTRODUCTION:Most of the optimization of HPLC method development have been focused on the optimization of HPLC conditions. This article will look at this topic from other perspectives. Forced degradation or stress testing is undertaken to demonstrate specificity when developing stability-indicating methods, particularly when little information is available about potential degradation products. These studies also provide information about the degradation pathways and degradation products that could form during storage.

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Selection of high-performance liquid chromatographic methods in pharmaceutical analysis

Cited by 56 publications

References 14 publications

Recent Advances in the Analysis of Steroid Hormones and Related Drugs

Recent Advances in the Analysis of Steroid Hormones and Related Drugs

An Updated Review: Forced Degradation Study

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