Development and Validation of Rp-HPLC Method for Quantitation of Amoxicillin Trihydrate in Bulk and Pharmaceutical Formulations Using Box-Behnken Experimental Design

Beg, Sarwar; Kohli, Kanchan; Swain, Sanjit Kumar; Hasnain, M. Saquib

doi:10.1080/10826076.2011.601493

Cited by 60 publications

(22 citation statements)

References 15 publications

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“…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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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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“…A calibration graph was plotted by taking peak area versus concentration. The correlation coefficient, intercept, slope and linear regression analysis was done [9].…”

Section: Linearity and Rangementioning

confidence: 99%

Simultaneous Estimation of Linagliptin and Metformin HCL in Human Plasma by Rp-HPLC Method

Balamurugan¹,

Mishra²,

Suresh³

2019

Int. Res. J. Pharm.

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A new and simple method was developed for quantitative determination of Linagliptin (LINA) and Metformin (MET) spiked with plasma using an Onyx C18 Monolithic column connected with an Onyx C18 guard cartridge and PDA detection at 220 nm. The optimized mobile phase acetonitrile (ACN), methanol (MeOH), formic acid (HCOOH) was pumped at 0.892 mL/min. The method was linear between 0.02-0.1 µg/mL, statistically validated for its linearity, precision, and accuracy. The precision was found to be less than 1% in the assay method. It was found that the additives in the commercial tablet did not interfere with the method. The currently developed method can routinely use for the estimation of LINA and MET related compounds from the tablet dosage form spiked with plasma.

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“…Moreover, DOE permits the buildup of a statistical model that allows appraisal of the significance and also statistical acceptation of the various factor effects on the responses being examined and in addition assess the mutual interactions between them (Ferreira et al 2007). Literature survey acknowledged that several analytical methods have been reported for optimization of chromatographic conditions in high-performance liquid-chromatography (HPLC) methods using Box-Behnken design (Gumustas et al 2018;De Almeida Borges et al 2013; Zacharis and Vastardi 2018;Dragomiroiu et al 2015;Awotwe-Otoo et al 2012;Bai et al 2010;Beg et al 2012;Gomes et al 2017;Ihssane et al 2011;Jovanov et al 2015;Mirza andTan 2001 andPatel et al 2017).…”

Section: Introductionmentioning

confidence: 99%

Design of experiment avenue for development and validation of RP-HPLC-PDA method for determination of apremilast in bulk and in in-house tablet formulation

Chaudhari

Shirkhedkar

2019

J Anal Sci Technol

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Background: Apremilast is phosphodiesterase-4 and an immunomodulating agent used for treatment of refractory psoriatic arthritis. Methods: The reversed-phase high-performance liquid-chromatography method for analysis of apremilast was developed and validated as per ICH guidelines. The separation of apremilast was performed on PrincetonSPHERE Ultima C18 column (250 mm × 4.6 mm, i.d., 5 μm particle size) with photodiode array detection carried out at 231 nm. A Box-Behnken design with response surface methodology was executed out for optimization of chromatographic conditions of reversed-phase high-performance liquid-chromatography for finished desired chromatographic separation of apremilast from its formulation with less number of experimental trials. Three independent factors, namely methanol composition in the mobile phase, pH of an aqueous phase, and flow rate, were used to construct a mathematical model and study the effects of these independent factors on responses such as retention time, theoretical plates, and tailing factor. Results: Optimized experimental conditions for proposed work consists of methanol and water, pH 3.50 adjusted with ortho-phosphoric acid (70:30 % v/v) as a mobile phase at a flow rate 1 ml/min with a retention time was found to be 5.15 min. Accuracy study was completed at three different levels and was found in the range of 99.44-101.49%. Conclusion: The 3D response surface graphs revealed that the methanol composition and pH of an aqueous phase were both most stringent factors affecting the responses. Thus, a new, precise, and accurate HPLC method was developed and validated and can be used for regular analysis of apremilast.

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Development and Validation of Rp-HPLC Method for Quantitation of Amoxicillin Trihydrate in Bulk and Pharmaceutical Formulations Using Box-Behnken Experimental Design

Cited by 60 publications

References 15 publications

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

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

Simultaneous Estimation of Linagliptin and Metformin HCL in Human Plasma by Rp-HPLC Method

Design of experiment avenue for development and validation of RP-HPLC-PDA method for determination of apremilast in bulk and in in-house tablet formulation

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