Efficient method development strategy for challenging separation of pharmaceutical molecules using advanced chromatographic technologies

Xiao, Kang; Xiong, Yuan; Liu, Fang Zhu; Rustum, Abu M.

doi:10.1016/j.chroma.2007.06.027

Cited by 53 publications

(21 citation statements)

References 11 publications

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“…GC-FID [24,25], and GC-EI-MS [9,[26][27][28][29] are the typical analytical approaches. As with HPLC, a variety of extraction and/or pre-concentration techniques, which are designed to improve matrix interference prior to GC analysis, were routinely used for traditional Chinese herbal medicines.…”

Section: Resultsmentioning

confidence: 99%

“…Xiao et al [9] recently reported on the separation of an epimeric pair of steroidal epoxides (16␣-methyl epoxide and 16␤-methyl epoxide), which are key intermediates for the corticosteroids, betamethasone and dexamethasone. They developed a fast HPLC method that separated the epimers with a resolution factor >3.0 and which had an LOQ of 0.0001% w/w (1 ppm) for the unwanted epimer.…”

Section: High Performance Liquid Chromatography (Hplc)mentioning

confidence: 99%

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Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals

Elder

Snodin

Teasdale

2010

Journal of Pharmaceutical and Biomedical Analysis

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Section: Resultsmentioning

confidence: 99%

Section: High Performance Liquid Chromatography (Hplc)mentioning

confidence: 99%

Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals

Elder

Snodin

Teasdale

2010

Journal of Pharmaceutical and Biomedical Analysis

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“…If the number of degradant peaks is the same in both separations, and if the are percent of the main component is the same in both separations, then there can be reasonable confidenc that all the degradants have been resolved from the main component. Automated versions of this approach have been successfully utilized in a multidimensional screening with instrumentation capable of systematically evaluating several different columns and eluents for impurity analysis [27][28][29] .…”

Section: Figure 1: Normalised Signals For Pure and Impure Peakmentioning

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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“…Each RP-HPLC column was tested by the specificity test mixture solution in at least three gradient programs. The simulation procedure was performed similar to the previously described steps [19].…”

Section: Optimization Of Mobile Phase Stationary Phase and Hplc Parmentioning

confidence: 99%

Development and validation of a stability-indicating HPLC method for simultaneous determination of salicylic acid, betamethasone dipropionate and their related compounds in Diprosalic Lotion®

Shou¹,

Galinada²,

Wei³

et al. 2009

Journal of Pharmaceutical and Biomedical Analysis

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Efficient method development strategy for challenging separation of pharmaceutical molecules using advanced chromatographic technologies

Cited by 53 publications

References 11 publications

Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals

Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals

Untitled

Development and validation of a stability-indicating HPLC method for simultaneous determination of salicylic acid, betamethasone dipropionate and their related compounds in Diprosalic Lotion®

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