Application of Taguchi OA and Box–Behnken Design for the Implementation of DoE-based AQbD Approach to HPTLC Method for Simultaneous Estimation of Azilsartan and Cilnidipine

Prajapati, Pintu; Tailor, Pratik M.; Shahi, Abhinandan; Acharya, Aneri; Shah, Shailesh

doi:10.1093/chromsci/bmac045

Cited by 6 publications

(3 citation statements)

References 21 publications

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“…In a controlled laboratory environment, the responses of the peaks corresponding to the two drugs were meticulously evaluated through a series of experimental runs prescribed by the Design-Expert software. 19 Utilizing the software, responses were assigned to each experimental run, enabling a comprehensive analysis of the box-behnken design. The data generated from these experimental runs were then subjected to Analysis of Variance (ANOVA) to discern significant effects and interactions.…”

Section: Response Surface Methodology (Rsm) Based Box-behnken Design ...mentioning

confidence: 99%

Stability-Indicating HPTLC Method for Concurrent Estimation of Triacontane and Beta-Sitosterol in Ailanthus excelsa Roxb.: A DoE Approach

Gudasi,

Patil,

Chougla

et al. 2024

J. Young Pharm.

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Background: Triacontane and beta-sitosterol, though promising in various applications, face challenges due to low solubility and susceptibility to photosensitivity. Enhancing their effectiveness requires overcoming these limitations. Design of Experiment (DoE) coupled with High-Performance Thin Layer Chromatography (HPTLC) offers a potent approach to address these issues. Materials and Methods: The HPTLC method was optimized using a Box-Behnken Design (BBD), considering factors like saturation time, migration distance and application length. Response Surface Methodology (RSM) was employed to analyze critical risk factors' effects on the method. Validation parameters, including linearity, accuracy, precision, robustness, solution stability and forced degradation studies, were assessed according to ICH guidelines. Additionally, a different fractions of Ailanthus excelsa Roxb. plant extracts was analyzed. Results: Triacontane and beta-sitosterol displayed distinct R f values of 0.94±0.010 and 0.75±0.02 for triacontane and beta-sitosterol, respectively. The method demonstrated excellent linearity across the concentration range of 2-10 mg/band, with correlation coefficients of 0.999 triacontane and 0.9989 beta-sitosterol, respectively. Percentage recovery for both found within the range of 98.84-102.92%. This validated method offers specificity and robustness, ideal for routine quality control testing in pharmaceutical applications. Solution stability and forced degradation studies further supported the method's stability-indicating nature. Conclusion: The stability-indicating HPTLC method, developed and validated using DoE approach, proved suitable for simultaneous estimation of triacontane and beta-sitosterol in Ailanthus excelsa Roxb. plant extracts. Compliance with ICH guidelines, coupled with robustness and specificity, positions it as a valuable tool for quality evaluation and standardization of herbal formulations.

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Section: Response Surface Methodology (Rsm) Based Box-behnken Design ...mentioning

confidence: 99%

Stability-Indicating HPTLC Method for Concurrent Estimation of Triacontane and Beta-Sitosterol in Ailanthus excelsa Roxb.: A DoE Approach

Gudasi,

Patil,

Chougla

et al. 2024

J. Young Pharm.

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“…For estimation of a combined dosage form of AZL and CLN, UV [29], HPLC [30][31], and HPTLC [32] methods have been reported. The reported UV method [29] was developed using the simultaneous equation method.…”

Section: Introductionmentioning

confidence: 99%

Liquid chromatographic method for simultaneous estimation of anti‐hypertensive drug combination Azilsartan Medoxomil and Cilnidipine

Solanki¹,

Panday²,

Shah³

et al. 2023

Separation Science Plus

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A combination of Azilsartan Medoxomil and Cilnidipine is prescribed in the treatment of Hypertension. An accurate and precise high‐performance liquid chromatographic method has been developed for the estimation of Azilsartan Medoxomil and Cilnidipine in a combined tablet dosage form. Symmetry C18 (250 × 4.6 mm, 5 μm) column was used as the stationary phase, and methanol:water (85:15 v/v; pH 3.5) was used as the mobile phase. The method was linear in the concentration range of 4–20 μg/ml for Azilsartan Medoxomil and 1–5 μg/ml for Cilnidipine with a correlation coefficient (r2) 0.995 for Azilsartan Medoxomil and 0.995 for Cilnidipine. The proposed method was validated with respect to linearity, accuracy, precision, and robustness as per International Council on Harmonization Q2 (R1) guideline. A forced degradation study was performed to find out the intrinsic stability of the molecules. The degradation products were well resolved from the drug peak and did not interfere with the analysis. The method was successfully applied for the analysis of Azilsartan Medoxomil and Cilnidipine in combined tablet formulation.

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“…In recent years, numerous AQbD‐based chromatographic methods have been reported in the literature for the analysis of drugs. Hence, the AQbD‐based chromatographic method is the best alternative to support concepts of WAC and green analytical chemistry [5–27].…”

Section: Introductionmentioning

confidence: 99%

White analytical chemistry‐driven stability‐indicating concomitant chromatographic estimation of thiocolchicoside and aceclofenac using response surface analysis and red, green, and blue model

Prajapati¹,

Pulusu

Shah³

2023

J of Separation Science

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White analytical chemistry is a novel concept for the assessment of analytical methods on basis of its validation efficiency, greenness power, and economical efficiency. White analytical chemistry‐driven stability indicating chromatographic method has been developed for the concomitant analysis of thiocolchicoside and aceclofenac. The proposed chromatographic method has been developed using a safe and environmental‐friendly organic solvents for the concomitant stability study of thiocolchicoside and aceclofenac. The analytical risk assessment was carried out for the identification of high‐risk analytical risk factors and analytical method performance attributes. The mixture design was applied for the design of experiments‐based response surface modeling of high‐risk analytical risk factors and analytical method performance attributes. The degradation products were isolated and characterized using infrared, nuclear magnetic resonance, and mass spectral data. The proposed method was compared for its validation efficiency, greenness power, and cost‐efficiency with published chromatographic methods using the red, green, and blue models. The white score of the proposed and reported method was calculated by averaging the red, green, and blue scores of the methods. The proposed method was found to be robust, green, and economical for the concomitant stability study of thiocolchicoside and aceclofenac.

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Application of Taguchi OA and Box–Behnken Design for the Implementation of DoE-based AQbD Approach to HPTLC Method for Simultaneous Estimation of Azilsartan and Cilnidipine

Cited by 6 publications

References 21 publications

Stability-Indicating HPTLC Method for Concurrent Estimation of Triacontane and Beta-Sitosterol in Ailanthus excelsa Roxb.: A DoE Approach

Stability-Indicating HPTLC Method for Concurrent Estimation of Triacontane and Beta-Sitosterol in Ailanthus excelsa Roxb.: A DoE Approach

Liquid chromatographic method for simultaneous estimation of anti‐hypertensive drug combination Azilsartan Medoxomil and Cilnidipine

White analytical chemistry‐driven stability‐indicating concomitant chromatographic estimation of thiocolchicoside and aceclofenac using response surface analysis and red, green, and blue model

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