Design of Experiments (DoE) - Based Enhanced Quality by Design Approach to Hydrolytic Degradation Kinetic Study of Capecitabine by Eco-friendly Stability Indicating UV-Visible Spectrophotometry

Prajapati, Pintu; Patel, Ranjan G.; Patel, Dilan; Shah, Shailesh

doi:10.46624/ajptr.2020.v10.i6.008

Cited by 20 publications

(5 citation statements)

References 9 publications

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“…Analytical Eco-Scale and GAPI approaches were used to estimate an analytical method's greenness [ 33 – 35 ]. The proposed approach is a great green method of analysis with few laboratory’s needs, according to the two methods (Table 10 ; Fig.…”

Section: Resultsmentioning

confidence: 99%

Green quality by design HPLC approach for the simultaneous determination of Bilastine and Montelukast

et al. 2023

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For the simultaneous estimation of two co-formulated antihistaminic drugs (Bilastine and Montelukast), a novel and eco-friendly reversed-phase HPLC approach with both diode array and fluorescence detection modes was designed. Rather than using the routine methodology, the Quality by Design (QbD) approach was adopted to speed up the method development and to test robustness of the method. To evaluate the effect of variable factors on chromatographic response, a full factorial design was used. The chromatographic separation was performed using isocratic elution on the C18 column. The mobile phase consists of 92% methanol, 6% acetonitrile, and 2% phosphate buffer with 0.1 (v/v) triethylamine adjusted to pH 3, it was pumped at a flow rate of 0.8 mL/min with an injection volume of 20 μL. The developed stability indicating HPLC approach was used to assess the stability of montelukast (MNT). It was subjected to a variety of stress conditions, including hydrolytic (acid–base), oxidative, thermal, and photolytic stress conditions. All of these conditions were found to have relevant degradation pathways. Under the described experimental conditions, MNT degradation followed pseudo-first-order kinetics. The kinetic parameters of its degradation (rate constant and t1/2) were calculated and a proposal for the degradation pathway was postulated.

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Section: Resultsmentioning

confidence: 99%

Green quality by design HPLC approach for the simultaneous determination of Bilastine and Montelukast

et al. 2023

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“…The data were also subjected to response surface methodology to determine the influence of mobile phase composition, flow rate, and column oven temperature on dependent variables. The probable trial runs using 3 3 Box Behnken designs are shown in Table 2.…”

Section: Optimization Of Developed Rp-hplc Methods With Design Space ...mentioning

confidence: 99%

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2023

IJPSR

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A simple, specific, accurate, reliable, and precise reverse-phase highperformance liquid chromatographic method was developed by quality by design approach and validated for the estimation of Capecitabine in bulk and tablet dosage forms. A surface methodology was used to optimize the data with a three-level Box Behnken Design (BBD) was used. Mobile phase composition, flow rate, and column oven temperature were chosen as the three variables. The linearity was over the concentration range of 1-15 μg/ml with a correlation coefficient of 0.999. The LOD and LOQ were found to be 0.103 ug/mL and 0.313 ug/mL, respectively. Chromatographic separation was carried out by using a mobile phase of methanol: water (70:30 V/V) on Kromasil C18 column (250 mm X 4.6mm ID, 5 μm) in an isocratic mode at a flow rate of 0.9 ml/min with UV detection at 239 nm. The developed RP-HPLC method yielded a suitable retention time for Capecitabine of 4.70 min, which was optimized using the Design-Expert version 7.0.0. The percentage recovery was found to be 99.81%. The RSD percentage for methods precision was less than 2%. The developed methods were found to be precise and accurate for estimating Capecitabine in pharmaceutical dosage forms and could be used for routine analysis.

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“…Literature survey reveals that various methods have been reported for capecitabine individually or in combination with other drugs those are UV 3,6,12,15 HPLC 8,14 , stability indicating 2,4,15 , stability by LC-MS 16 , Stability UV by QbD 17,18 , but no one has developed RP-HPLC by Quality by Design method of these drug, which is fast, simple, and sensitive with less run time and good peak symmetry. Finally, the established method was validated with respect to specificity, linearity, precision, accuracy, robustness, LOD and LOQ according to ICH guidelines.…”

Section: Figmentioning

confidence: 99%

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2024

IJPSR

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It belongs to the group of medications called as anti-metabolites and is a fluoropyrimidine carbonate with anti-cancer properties. The chemotherapy drug capecitabine is taken orally and is used to treat metastatic colorectal and breast cancers. A review of the literature reveals several analytical techniques have been developed for Capecitabinein single and combined with other drugs. No QbD-assisted RP-HPLC method is available to estimate Capecitabine. So, present work describes the development and validation of QbD driven RP-HPLC method for Capecitabine. This method has been developed using Agilent 1100 series HPLC with ODS (water) column (150 × 4.5mm, 5 µm). Based on the RP-HPLC method development Mobile phase and Flow rate were selected as CAA and retention time, peak area, theoretical plates, tailing factor of drug were monitored using Design Expert 13.0.0.5. By applying CCD, 8 trials having 2 factors and 4 responses method had been selected for method development of capecitabine. The optimum method development was selected based on the criteria of Retention time, Peak area, Theoretical plates, Tailing factor. The retention time of Capecitabine is 2.721 min. The method was validated for specificity, linearity, accuracy, precision, limit of quantification, limit of detection, robustness in accordance with ICH guidelines. Limit of detection and limit of quantification for estimation of Capecitabine found to be 0.2371 µg/mL and 0.7185 µg/mL. INTRODUCTION:Capecitabine CAP [N4pentoxycarbonyl-5-deoxy-5-fluorocytidine] is an anticancer prodrug of 5-fluorouracil (5-FU) that was designed to undergo preferential conversion to 5-FU within tumors 1 . 5-FU has also been widely used as an anticancer agent in the chemotherapy of solid tumors but its efficacy is limited by dihydropyrimidine dehydrogenase catalyzed formation of dihydro-5-fluorouracil 2 .

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Design of Experiments (DoE) - Based Enhanced Quality by Design Approach to Hydrolytic Degradation Kinetic Study of Capecitabine by Eco-friendly Stability Indicating UV-Visible Spectrophotometry

Cited by 20 publications

References 9 publications

Green quality by design HPLC approach for the simultaneous determination of Bilastine and Montelukast

Green quality by design HPLC approach for the simultaneous determination of Bilastine and Montelukast

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