Quantitative Estimation and Validation of Chlorthlidone and Azilsartan Medoximil in Bulk and Tablet Dosage Form by using RP-HPLC

Dighe, Nachiket S; Thorat, Somnath K.; Shinde, Ganesh S.; Dhamak, Kavita V

doi:10.22270/jddt.v9i4-s.3315

Cited by 10 publications

(2 citation statements)

References 1 publication

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“…The chemical structures of AZL and CIL are shown in Figure 1. Numerous RP-HPLC methods have been published in the literature for the estimation of AZL alone and with other drugs [12][13][14][15][16][17][18][19][20], CIL alone, and with other drugs [21][22][23][24][25] in their FDCs. Recently, some chromatographic methods such as RP-HPLC and ultra-performance liquid chromatography methods have been reported in the literature for simultaneous estimation of AZL and CIL using class 2 solvents (methanol and acetonitrile) as mobile phase and diluent [26][27][28].…”

Section: Introductionmentioning

confidence: 99%

Robust method operable design region for economical and eco‐friendly chromatographic analysis of azilsartan medoxomil and cilnidipine by incorporating a hybrid approach of green analytical chemistry and analytical quality by design

Prajapati,

Shahi,

Acharya

et al. 2023

Separation Science Plus

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According to the concept of green analytical chemistry, the analytical method development should be carried out by avoiding or minimizing the usage of toxic organic solvents for the safety of human and aquatic animal life and the protection of the environment. Hence, the green analytical chemistry (GAC)‐assisted robust liquid chromatographic method has been developed for chromatographic analysis of azilsartan medoxomil and cilnidipine (CIL) using safe organic solvents. The chromatographic method was developed by the implementation of analytical quality by design using chemometrics and response surface modeling. The chromatographic separation was carried out using Shim‐Pack C18 (250 × 4.6 mm, 5.0 μm) column as stationary phase and ethanol: 0.1% V/V ammonia solution (45:55, %V/V) as mobile phase. The chromatographic peak of AZL and CIL was found to be at the retention time of 3.5 and 4.5 min, respectively. The flow rate was kept at 1.0 mL/min and the column oven temperature was set to 40˚C. The developed method was found to be validated as per the International Council for Harmonization Q2 (R1) guideline. The method was applied for the assay of fixed‐dose combination and results were found in compliance with the labeled claim. The greenness of the method was evaluated using GAC tools.

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Section: Introductionmentioning

confidence: 99%

Robust method operable design region for economical and eco‐friendly chromatographic analysis of azilsartan medoxomil and cilnidipine by incorporating a hybrid approach of green analytical chemistry and analytical quality by design

Prajapati,

Shahi,

Acharya

et al. 2023

Separation Science Plus

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show abstract

“…3 Azilsartan is crystalline powder in nature having off-white color and soluble in methanol and partially soluble in acetonitrile and insoluble in water. The literature review on the availability of analytical methods for Azilsartan revealed a UV spectroscopic method, 7 few ultra-performance liquid chromatographic method and LC-MS methods for the quantification of Azilsartan in bulk drug, plasma 8,9 and combination with other drugs 10,11 and stability-indicating high-performance thin layer chromatographic (HPTLC) method. 12 In the literature survey, many chromatographic analytical methods were developed having several drawbacks include high buffer concentration leads to column damage, time-consuming and tedious.…”

Section: Introductionmentioning

confidence: 99%

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

Deshmukh¹,

Vanjari²,

Patil³

et al. 2020

IJPER

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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

Prajapati¹,

Tailor²,

Shahi³

et al. 2022

Journal of Chromatographic Science

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Hypertension is the most prominent disease found in people due to stressful routines and the working environment. The fixed-dose combination (FDC) of azilsartan medoxomil (AZL) and cilnidipine (CLN) is used for the treatment of hypertension. According to the green chemistry approach, organic solvents should be minimized in the development of the analytical method for the safety of the environment. The high-performance thin-layer chromatographic (HPTLC) method required less amount of organic solvent for the analysis of the drug. Hence, it was thought of interest to develop an accurate and robust HPTLC method for the estimation of AZL and CLN in their FDC. The development of the method was carried out by the implementation of the analytical quality by design approach using the Taguchi orthogonal array and BBD for regulatory compliance as per the upcoming ICH Q14 guideline. The analytical design space and control strategy was framed for the lifecycle management of the method. The chromatographic separation was performed using silica gel GF254 and toluene ethylacetate–methanol (6.5 + 1.5 + 2.0, v/v). The method was applied for the assay of FDC and results were found in compliance with the labeled claim. The developed method was also applied for the estimation of spiked human plasma and the recovered amount of drugs was found in the range of 80–85%.

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Quantitative Estimation and Validation of Chlorthlidone and Azilsartan Medoximil in Bulk and Tablet Dosage Form by using RP-HPLC

Cited by 10 publications

References 1 publication

Robust method operable design region for economical and eco‐friendly chromatographic analysis of azilsartan medoxomil and cilnidipine by incorporating a hybrid approach of green analytical chemistry and analytical quality by design

Robust method operable design region for economical and eco‐friendly chromatographic analysis of azilsartan medoxomil and cilnidipine by incorporating a hybrid approach of green analytical chemistry and analytical quality by design

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

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

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