Application of Design of Experiment Based Innovative Approach in Method Development and Validation of RP-HPLC for Estimation of Azilsartan in Bulk and Pharmaceutical Tablet Dosage Form

Deshmukh, Siddhata Arjun; Vanjari, Suvarna; Patil, Rashmee; Khandelwal, K. R.

doi:10.5530/ijper.54.3s.165

Cited by 2 publications

(1 citation statement)

References 18 publications

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“…Only a few approaches are described in the literature for the estimation of AZL and CIL (Andhalea and Nikalje, 2022; O n l i n e F i r s t Jani andPatel, 2018a, 2018b;Jena et al, 2021;Solanki et al, 2022). However, several high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectroscopy techniques for estimating AZL and CIL alone or combined with other drugs are reported (Desai and Nikalje, 2021;Deshmukh et al, 2020;Ghante et al, 2019;Kumar and Begum, 2019;Rathod et al, 2018;Ruhina and Mamatha, 2017;Soliman et al, 2019;Surwade and Saudagar, 2015;Vyas et al, 2019). Only the high-performance thin layer chromatography (HPTLC) method was reported for AZL by the QbD approach (Prajapati et al, 2022).…”

Section: Introductionmentioning

confidence: 99%

AQbD-based stability indicating development and validation of azilsartan medoxomil and cilnidipine by UPLC method

Bandi¹,

Adikay²

2023

J App Pharm Sc

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This work describes a chromatographic technique for quantifying azilsartan medoxomil (AZL) and cilnidipine (CIL) in bulk and pharmaceutical formulations using quality by design (QbD). The analytical targeting profile distribution and critical analytical attributes (CAA) are incorporated with analytical QbD. Risk evaluation studies and factor screening research facilitate the identification of critical method parameters (CMPs). The application of 2 2 full factorial designs was used to optimize the process. Selected CMPs, such as plate number of peak 1 (R1), resolution (R2), and tailing factor of peak 2 (R3) were evaluated. Utilizing statistical data and response surface plots, the individual and interaction effects of CMP on CAA were evaluated. The significance (p ˂ 0.05) of the procedure parameters was shown by analysis of variance. Mobile phase-Acetonitrile and 1% triethylamine buffer (50:50 v/v), pH (2.5) adjusted with 0.1% ortho-phosphoric acid, and Waters X-Bridge C18 column, (50 × 4.6 mm, 2.5 µm), the flow rate is 0.5 ml/minute with photodiode array detector at 273 nm. According to ICH requirements, method validation and subsequent stress degradation experiments were carried out. All variables are within their bounds. The suggested method is effectively illustrated by using a QbD to perform extremely sensitive, stable, and suited for regular analysis and clinical applications.

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Section: Introductionmentioning

confidence: 99%

AQbD-based stability indicating development and validation of azilsartan medoxomil and cilnidipine by UPLC method

Bandi¹,

Adikay²

2023

J App Pharm Sc

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Response Surface Methodology-Based Quantification of Lamivudine and Zidovudine Using Reverse-Phase High-Performance Liquid Chromatography in Pharmaceutical Formulation

Shah

Chauhan

Yadav

et al. 2022

Asian Journal of Pharmaceutical Research and Health Care

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Objective: A novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for estimation of lamivudine and zidovudine by using an experimental design approach applying the response surface technique was developed and validated using a C18 column and its application in marketed formulation. Multivariate optimization of experimental conditions was achieved using experimental design employing organic content in the mobile phase, pH, and flow rate of the mobile phase as three independent variables. The aim of this study was to apply response surface methodology and to study the effect of the independent variables on the separation and estimation of both drugs by the RP-HPLC method using a faced central composite experimental design. Materials and Methods: Derringer's desirability function was used to optimize the retention period of the last eluting peak and peak symmetry, and it was discovered that the optimal conditions were potassium dihydrogen phosphate buffer and acetonitrile in an isocratic ratio of 55:45 w/v, pH 3.5, and 0.4 ml/min flow rate. Baseline separation of both medications with good resolution and a run time of more than 7 min was accomplished using this ideal condition. Results: For lamivudine and zidovudine, a linear response was seen over the concentration range of 2–12 and 4–24 μg/mL, respectively. Lamivudine's limit of detection and limit of quantitation were determined to be 3.08 and 9.18 μg/mL, respectively, whereas zidovudine's values were 3.24 and 10.17 μg/mL. According to the ICH guidelines acceptance criteria for linearity, accuracy, precision, specificity, and robustness, the method was successfully validated.

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Application of Design of Experiment Based Innovative Approach in Method Development and Validation of RP-HPLC for Estimation of Azilsartan in Bulk and Pharmaceutical Tablet Dosage Form

Cited by 2 publications

References 18 publications

AQbD-based stability indicating development and validation of azilsartan medoxomil and cilnidipine by UPLC method

AQbD-based stability indicating development and validation of azilsartan medoxomil and cilnidipine by UPLC method

Response Surface Methodology-Based Quantification of Lamivudine and Zidovudine Using Reverse-Phase High-Performance Liquid Chromatography in Pharmaceutical Formulation

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