A practical approach to method validation in pharmaceutical analysis

Carr, Geoff; Wahlich, John

doi:10.1016/0731-7085(90)80090-c

Cited by 134 publications

(53 citation statements)

References 6 publications

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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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“…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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“…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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“…Different validation tests were applied to assess the reliability of the proposed method (Caporal et al, 1990;Carr and Wahlich, 1990). Linearity of the method was determined for each compound for six concentrations ranging from 0.67 to 67.5 µg.L -1 for T, 0.83 to 83.3 µg.L -1 for TP and 0.92 to 92.1 µg.L -1 for TPP.…”

Section: Validation Proceduresmentioning

confidence: 99%

Evaluation of vitamin B1 status of alcoholic subjects in Abidjan (Côte d'Ivoire)

Aké¹,

N’cho²,

Bony³

et al. 2010

International Journal of Biological and Chemical Sciences

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Given the clinical importance of free thiamine and its esters on the essential human organs, their determination seems necessary to appreciate vitamin B1 status in physiological and pathological states of local populations. The present preliminary study describes a method of analysis of free thiamine and its phosphate esters: thiamine monophosphate and thiamine diphosphate by reverse phase liquid chromatography and fluorimetric detection. Validation tests were applied to verify the reliability of the proposed method. The results indicated that the chromatographic system was suitable for chromatographic analysis of free thiamine and its esters in whole. Thus, the method was applied to whole blood samples of 35 alcoholic patients under alcoholic detoxification cure in Abidjan. The results of the application showed that 100% of the alcoholic subjects presented a total thiamine concentration under the accepted norm of 20µg.L -1 . Before the cure at Day 0, 74,28% of the subjects presented a severe deficiency. After 30 days, all of the subjects still presented a marginal status of vitamin B1. Thiamine supplementation included in the alcoholic detoxification cure seems to improve its status. However, it seems that the latter should be of sufficient duration to ensure the return to an effective normal vitamin B1 status.

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A practical approach to method validation in pharmaceutical analysis

Cited by 134 publications

References 6 publications

An Updated Review: Forced Degradation Study

An Updated Review: Forced Degradation Study

Untitled

Evaluation of vitamin B1 status of alcoholic subjects in Abidjan (Côte d'Ivoire)

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