Quality-By-Design Approach to Stability Indicating RP-HPLC Analytical Method Development for Estimation of Canagliflozin API and Its Validation

Bossunia, Mohammad Tarikul Islam; Urmi, Khandokar Farjana; Shaha, Chironjit Kumar

doi:10.5530/phm.2017.8.15

Cited by 18 publications

(7 citation statements)

References 3 publications

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“…The literature review reveals methods for the estimation of CAN in biofluids, humans, and rat plasma by liquid chromatography–mass spectrometry (LC/MS/MS) , and high-performance liquid chromatography (HPLC) − and the determination of related substances in CAN . Few methods using HPLC, − HPTLC, and UV , methods for the estimation of CAN in bulk or its pharmaceutical form have been documented. The reported conventional methods were tedious and fretful, requiring a large number of experimental runs, and always yielded a narrow robust method that has a high risk of failure during transfer/real-time usage.…”

Section: Introductionmentioning

confidence: 99%

Analytical Quality by Design-Assisted HPLC Method for Quantification of Canagliflozin and Stability Studies

Azhakesan

Sujatha

2023

ACS Omega

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The present study is intended to develop the high-performance liquid chromatography (HPLC) method for the analysis of Canagliflozin using the analytical quality by design (AQbD) approach. The key parameters were methodically optimized with the help of factorial experimental design, and contours were plotted when investigated using Design Expert software. A stability-indicating high-performance liquid chromatography (HPLC) technique was developed and validated for the quantitative estimation of Canagliflozin, and its stability was assessed using various forced degradation conditions. Successful separation of Canagliflozin was accomplished using a Waters HPLC system with a photo diode array (PDA) detector and Supelcosil C18 column (250 × 4.6 mm, 5 μm) and 0.2% v/v solution of trifluoroacetic acid in water/acetonitrile (80:20% v/v) as the mobile phase maintaining the flow rate at 1.0 mL/min. The detection wavelength was 290 nm, and Canagliflozin got eluted at 6.9 min with a run time of 15 min. Canagliflozin peak purity values in all degradation conditions indicated that the peak is homogeneous, and therefore this method can be considered stability-indicating. The proposed technique was found to be specific, precise (% RSD about 0.66%), linear (12.6−37.9 μg/mL), rugged (overall % RSD about 0.50%), and robust. The standard and sample solutions were stable after 48 h (cumulative % RSD about 0.61%). The developed AQbD-based HPLC method can be used for the assay of Canagliflozin in Canagliflozin tablets of regular production batches and stability samples.

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Section: Introductionmentioning

confidence: 99%

Analytical Quality by Design-Assisted HPLC Method for Quantification of Canagliflozin and Stability Studies

Azhakesan

Sujatha

2023

ACS Omega

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“…4 Many scientists have implemented the AQbD approaches and guidelines to chromatographic procedures. [5][6][7][8][9][10] The systematical and rational utilization and implementation of elements of QbD to analytical procedure optimization to obtain good performance of technique is known as AQbD. 11,12 This avenue gives surety of reliability and high quality of the analytical procedures and reduces the failure risk in the phase of standardization as well as routine quality analysis.…”

Section: Introductionmentioning

confidence: 99%

Box-Behnken Design Assisted Optimization and Standardization of Chromatographic Methodology for Quality Assessment of Metformin: Analytical Quality by Design Avenue

Suryawanshi¹,

Palled²

2022

IJPER

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Background: Metformin (MET) is an oral antidiabetic agent falls chemically under the category of biguanides and it is effectively utilized in the management of type 2 diabetes mellitus. It is marketed in the tablet dosage form and hence quality control and assessment of MET is very much essential and important. Objectives: The objectives of present research investigation are to implement the Box-Behnken Design (BBD) in the optimization and validation of Reverse Phase-High Performance Liquid Chromatographic (RP-HPLC) method for the quality assessment of MET and also to systematically apply the Analytical Quality by Design (AQbD) Approach. Materials and Methods: In methodology BBD was employed to identify and optimize the critical method aspects for augmenting the performance of proposed methodology. The optimum chromatographic elution was performed on Agilent C 18 (5µm, 250 × 4.6 mm i.d.) column employing methanol and 0.1% ortho phosphoric acid in water with pH 2.8 in the proportions of 4:96 v/v as solvent system. The elution was carried out at 0.7 mL/min flow of mobile phase and identification at 231 nm using UV detector. The BBD driven optimized method was standardized as per guidelines of International Council for Harmonisation Q2 (R 1 ) in terms of validating method parameters such as specificity, linearity, detection and quantitation limit, precision, robustness, ruggedness and accuracy. Results: The method was linear in the concentration of 5-25µg/ml with R 2 = 0.999. The detection and quantitation limit were obtained at concentration of 0.30 and 0.93 µg /ml. The values of precision, robustness, and ruggedness parameters were found to be well within the required limit of acceptance with deviation of relative standard < 2%. The accuracy of MET was observed 99.22% to 100.25% at three different recovery experiments. At the end the proposed design of experiment (DoE) oriented methodology successfully applied for quantification of MET. Conclusion: The BBD and AQbD approaches are highly useful for the quality assessment of MET in bulk and its marketed tablet dosage forms.

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“…QbD approach facilitates science and risk-based understanding of the major sources of variability, followed by the identification of critical method parameters (CMPs) using risk assessment and factor screening studies. The high-risk variables with a critical impact on the analytical method performance are screened and optimized using suitable experimental designs for augmenting method performance [9]. In the past few decades, literature reports on diverse drugs have vouched for the phenomenal benefits of the QbD approach for developing the analytical methods for drug substances, impurities, and degradation products effectively and cost-effectively [10].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Novel Rp-HPLC-Dad Method for Quantification of Lapatinib Ditosylate in Newer Nano-Liposome Formulation: A Quality by Design (Qbd) Approach

Priyanka

Shaikh²,

HARER³

2022

Int J App Pharm

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Objective: The current study entails quality by design (QbD) enabled the development of a simple, rapid, sensitive, and cost-effective RP-HPLC method for estimation of Lapatinib ditosylate (LPT) in a newly prepared nano-liposomal formulation which has not been reported earlier. Methods: The chromatographic factors were screened using a fractional factorial design. A central composite design was employed as a response surface methodology. Mobile phase ratio, flow rate, and wavelength were identified as critical method parameters. To minimize retention time, peak area and theoretical plates were employed as critical analytical attributes. A novel nano-liposomal formulation of LPT was prepared by the film hydration method. Results: The optimized chromatographic condition was obtained at a mobile phase composition of methanol and 0.05% v/v o-phosphoric acid in water (81:19 v/v), flow rate 0.7 ml/min, and peak detected at wavelength 261 nm using DAD detector. The retention time for Lapatinib was 3.702 min. The developed method was validated as per ICH guidelines ICH Q2 (R1). Linearity (R2= 0.999) was observed in the range of 10-50μg/ml. The limit of detection and limit of quantitation was found to be 0.6309μg/ml and 1.9120μg/ml, respectively. LPT containing liposome formulation assay was found to be 99.03% and %RSD was less than 1%. Conclusion: The newly developed RP-HPLC method applying the QbD approach was found to be simple, specific, precise, accurate, linear, and rugged, with good recovery of LPT in the nano-liposome formulation in a cost-effective manner. Hence it can be employed for the quantification of LPT in bulk and pharmaceutical formulations.

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Quality-By-Design Approach to Stability Indicating RP-HPLC Analytical Method Development for Estimation of Canagliflozin API and Its Validation

Cited by 18 publications

References 3 publications

Analytical Quality by Design-Assisted HPLC Method for Quantification of Canagliflozin and Stability Studies

Analytical Quality by Design-Assisted HPLC Method for Quantification of Canagliflozin and Stability Studies

Box-Behnken Design Assisted Optimization and Standardization of Chromatographic Methodology for Quality Assessment of Metformin: Analytical Quality by Design Avenue

Development and Validation of Novel Rp-HPLC-Dad Method for Quantification of Lapatinib Ditosylate in Newer Nano-Liposome Formulation: A Quality by Design (Qbd) Approach

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