Quality by Design (QbD) approach to develop HPLC method for eberconazole nitrate: Application oxidative and photolytic degradation kinetics

Krishna, Marothu Vamsi; Dash, Rajendra N.; Reddy, B. Jalachandra; Venugopal, Parameswaran; Sandeep, P.; Madhavi, G.

doi:10.1016/j.jscs.2012.12.001

Cited by 51 publications

(20 citation statements)

References 12 publications

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“…Tetrabutyl ammonium hydroxide concentration, buffer pH and organic phase concentration Capacity factor of eberconazole nitrate (reverse phase HPLC method) (Krishna et al, 2016) Central composite design Cyclodextrin concentration, pH, and voltage Resolution between peaks and analysis time of a clycodextrin-modified micellar electrokinetic chromatography (Orlandini et al, 2016) Box-Behnken design Acetonitrile content in mobile phase, ammonium acetate concentration in the aqueous phase, and pH of aqueous phase Retention factor of impurity and selectivity of critical peal pair in bilastine and its degradation impurities determination by liquid chromatographic method (Terzic et al, 2016) Placket-Burman design Temperature, pH, buffer concentration, and L-asparaginase concentration Absorvance at 450 nm, usedfor L-asparaginase activity method (Yao et al, 2016) Fractionate factorial design Time of dissolution, volume of dissolution media, pH of dissolution media, and rotation speed Amount of acetaminophen dissolved during (Romero, Lourenço, 2017) as recent examples of the utilization of DoE in the development and optimization of analytical methods. DoE tools help to identify and explain how critical analytical parameters (CAPs) (independent variables) affects the analytical method performance characteristics (AMPC) (dependent variables) and, therefore, the analytical target profile (ATP).…”

Section: Applications Of Design Of Experiments In Qbd and Aqbdmentioning

confidence: 99%

Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

Fukuda

Pinto

Moreira

et al. 2018

Braz. J. Pharm. Sci.

225

111

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According to Quality by Design (QbD) concept, quality should be built into product/method during pharmaceutical/analytical development. Usually, there are many input factors that may affect quality of product and methods. Recently, Design of Experiments (DoE) have been widely used to understand the effects of multidimensional and interactions of input factors on the output responses of pharmaceutical products and analytical methods. This paper provides theoretical and practical considerations for implementation of Design of Experiments (DoE) in pharmaceutical and/or analytical Quality by Design (QbD). This review illustrates the principles and applications of the most common screening designs, such as two-level full factorial, fractionate factorial, and Plackett-Burman designs; and optimization designs, such as three-level full factorial, central composite designs (CCD), and Box-Behnken designs. In addition, the main aspects related to multiple regression model adjustment were discussed, including the analysis of variance (ANOVA), regression significance, residuals analysis, determination coefficients (R 2 , R 2-adj, and R 2-pred), and lack-of-fit of regression model. Therefore, DoE was presented in detail since it is the main component of pharmaceutical and analytical QbD.

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Section: Applications Of Design Of Experiments In Qbd and Aqbdmentioning

confidence: 99%

Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

Fukuda

Pinto

Moreira

et al. 2018

Braz. J. Pharm. Sci.

225

111

View full text Add to dashboard Cite

show abstract

“…Not only does design of experiments help in identifying the 'vital few' method variables critically influencing the method performance, but it also assists in optimizing them, while expending minimal resources of time, effort and cost. In the past a few years, the increasing acceptance of the rational QbD approaches has been a testimony to their ability to produce diverse chromatographic methods with distinctly enhanced method performance (Beg et al, 2011Krishna et al, 2012;Murthy et al, 2013;Rozet et al, 2012;Skrdla et al, 2009).…”

Section: Introductionmentioning

confidence: 99%

QbD‐oriented development and validation of a bioanalytical method for nevirapine with enhanced liquid–liquid extraction and chromatographic separation

Beg

Chaudhary

Sharma

et al. 2015

Biomedical Chromatography

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The present studies describe the systematic quality by design (QbD)-oriented development and validation of a simple, rapid, sensitive and cost-effective reversed-phase HPLC bioanalytical method for nevirapine in rat plasma. Chromatographic separation was carried out on a C18 column using isocratic 68:9:23% v/v elution of methanol, acetonitrile and water (pH 3, adjusted by orthophosphoric acid) at a flow rate of 1.0 mL/min using UV detection at 230 nm. A Box-Behnken design was applied for chromatographic method optimization taking mobile phase ratio, pH and flow rate as the critical method parameters (CMPs) from screening studies. Peak area, retention time, theoretical plates and peak tailing were measured as the critical analytical attributes (CAAs). Further, the bioanalytical liquid-liquid extraction process was optimized using an optimal design by selecting extraction time, centrifugation speed and temperature as the CMPs for percentage recovery of nevirapine as the CAA. The search for an optimum chromatographic solution was conducted through numerical desirability function. Validation studies performed as per the US Food and Drug Administration requirements revealed results within the acceptance limit. In a nutshell, the studies successfully demonstrate the utility of analytical QbD approach for the rational development of a bioanalytical method with enhanced chromatographic separation and recovery of nevirapine in rat plasma. Copyright © 2015 John Wiley & Sons, Ltd.

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“…The use of DoE in the development and optimization of chromatographic conditions is not exclusive for forced degradation studies; instead, its application has spread to several fields that use chromatography as a tool [86,87,88]. Krishna et al [89] performed forced degradation studies of eberconazole nitrate (EBZ) submitting it to hydrolytic (acid, basic, and neutral), thermal, oxidative, and photolytic degradation. In this work, a full factorial 3 3 design was used to identify the best conditions of the mobile phase for drug analysis.…”

Section: Applications Of Chemometric Tools In Forced Degradation Smentioning

confidence: 99%

“…The ranges studied in design were selected according to previous studies and considered the physicochemical properties of EZB. Other chromatographic parameters such as column dimensions, flow rate, injection volume, wavelength for detection, as well as the procedure performed in each degradation condition, can be found in reference [89].…”

Section: Applications Of Chemometric Tools In Forced Degradation Smentioning

confidence: 99%

Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs

Alvarenga

Carneiro

2019

Molecules

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Chemometrics is the chemistry field responsible for planning and extracting the maximum of information of experiments from chemical data using mathematical tools (linear algebra, statistics, and so on). Active pharmaceutical ingredients (APIs) can form impurities when exposed to excipients or environmental variables such as light, high temperatures, acidic or basic conditions, humidity, and oxidative environment. By considering that these impurities can affect the safety and efficacy of the drug product, it is necessary to know how these impurities are yielded and to establish the pathway of their formation. In this context, forced degradation studies of pharmaceutical drugs have been used for the characterization of physicochemical stability of APIs. These studies are also essential in the validation of analytical methodologies, in order to prove the selectivity of methods for the API and its impurities and to create strategies to avoid the formation of degradation products. This review aims to demonstrate how forced degradation studies have been actually performed and the applications of chemometric tools in related studies. Some papers are going to be discussed to exemplify the chemometric applications in forced degradation studies.

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Quality by Design (QbD) approach to develop HPLC method for eberconazole nitrate: Application oxidative and photolytic degradation kinetics

Cited by 51 publications

References 12 publications

Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

QbD‐oriented development and validation of a bioanalytical method for nevirapine with enhanced liquid–liquid extraction and chromatographic separation

Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs

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