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

Gurrala, Sunitha; Shivaraj,; CVS, None Subrahmanyam; Anumolu, Panikumar Durga; Saraf, Gowthami

doi:10.5530/ijper.53.4s.167

Cited by 15 publications

(6 citation statements)

References 15 publications

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“…Pareto analysis is a primary and secondary factor analysis method by creating Pareto diagrams [29], which assumes that 80% of the losses are mainly influenced by 20%, and therefore, focusing on 20% of the important factors can avoid 80% of the losses.…”

Section: Resultsmentioning

confidence: 99%

Quality by design‐based capillary electrophoresis method development for the quantitative analysis of four iridoid compounds in Gentiana macrophylla Radix

Zhang

et al. 2023

Electrophoresis

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In this study, the capillary electrophoresis‐photodiode array detector was employed for the analysis of four iridoid compounds in Gentiana macrophylla Radix (RGM), and the method was optimized based on the concept of analytical quality by design (AQbD). The peak areas relative standard deviation (n = 3) and resolution of the four analytes were selected as critical method attributes. Fractional factorial design test combined with Pareto analysis were employed to screen critical method parameters (buffer concentration, pH, sodium dodecyl sulfate [SDS] micelle concentration, temperature, and voltage). Subsequently, three main factors (buffer concentration, buffer pH, and SDS concentration) were selected by central composite design test for constructing the design space. The optimal separation conditions as follows: capillary column (50.2 cm × 50 µm, detection length 40 cm). Working background electrolyte consisted of 51 mmol/L borax solution (pH = 9.47) and 40 mmol/L SDS. The samples were injected by pressure (5 s at 0.5 psi) and the detection was performed at 254 nm. Applied voltage was 20 kV and column temperature was 23°C. The developed method is rapid and reliable for the quantitative analysis of four iridoid compounds in RGM, providing a reference for the application of AQbD concept in the analysis of natural products.

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Section: Resultsmentioning

confidence: 99%

Quality by design‐based capillary electrophoresis method development for the quantitative analysis of four iridoid compounds in Gentiana macrophylla Radix

Zhang

et al. 2023

Electrophoresis

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“…The major objective of AQbD has been to identify failure modes and establish a robust method operable design region or design space within meaningful system suitability criteria and continuous lifecycle management. If an AQbD approach has been implemented in the development stage, the flexibility of an analytical method is granted without the need for revalidation or regulatory review. − Stability testing is required to reveal the intrinsic stability properties of active pharmaceutical ingredients, according to the ICH guidelines for stability testing . The proposed chromatography technique is distinct from the literature following analytical method development through the QbD approach for quantitative estimation of CAN in API/pharmaceutical dosage form with the enactment of stability studies.…”

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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“…[1][2][3] Various techniques have been established for the estimation of CGF alone or in combination with metformin in pharmaceutical and bulk products. The liquid chromatography, 4 reverse phase-high performance liquid chromatography (RP-HPLC), 5,6 and HPLC 7,8 were reported for the estimation of CGF. Several analytical procedures were also established for the estimation of CGF 9 or simultaneous bio-analytical estimation of Metformin and CGF in human plasma like RP-HPLC 10 and liquid chromatography/ tandem mass spectrometry (LC-MS/MS).…”

Section: Introductionmentioning

confidence: 99%

Preformulation and UV-Spectrophotometric Analytical Method Validation Studies for Assessment of Canagliflozin

Shukla¹,

Sharma²,

Singh³

et al. 2022

IJPQA

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>The objectives of the present investigation were the physicochemical examination of canagliflozin to authenticate the drug’s characteristics and validation of straightforward and rapid ultraviolet-spectroscopy technique for evaluation of canagliflozin in phosphate buffer, pH 6.8. X-ray diffraction study revealed numerous peaks i.e. 11.41, 16.35, 16.5, 16.65, 18.53, 18.58, 19.55, 20.11, 20.46, 20.71, 21.62, 23.96, 24.17, 24.77, 26.5, 27.08, 27.68, 28.22, 28.73 and 32.6 at °2θ which demonstrated extremely crystalline character of drug. The regression equation for the standard plot was Y = 0.01957X + 0.036, and correlation coefficient was 0.9936. The method was found linear as indicated by correlation coefficient values of 0.9933, 0.9938, and 0.9943 for three consecutive standard plots. The average recovery of Canagliflozin was found to be 100.033% which was inside the prerequisite specification of the range 98 to 102%. The percentage relative standard deviation for repeatability, inter-day precision, intermediate precision, and robustness was less than 2%. The limit of detection (LoD) for Canagliflozin was 2.38 μg/mL, and the limit of quantitation was 7.24 μg/mL, which established the sensitivity of the UV-spectroscopy analytical method. In conclusion, the validation parameters like linearity, accuracy, repeatability, inter-day precision, intermediate precision, robustness, and sensitivity were found acceptable for the UV-spectroscopy analytical technique for analysis of Canagliflozin.

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

Cited by 15 publications

References 15 publications

Quality by design‐based capillary electrophoresis method development for the quantitative analysis of four iridoid compounds in Gentiana macrophylla Radix

Quality by design‐based capillary electrophoresis method development for the quantitative analysis of four iridoid compounds in Gentiana macrophylla Radix

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

Preformulation and UV-Spectrophotometric Analytical Method Validation Studies for Assessment of Canagliflozin

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