HPTLC Method for Simultaneous Estimation of Aliskiren, Amlodipine, and Hydrochlorothiazide in Synthetic Mixture Using Quality by Design Approach

Patel, Tushar R.; Patel, Tejas; Suhagia, Bhanubhai N.; Shah, Shailesh

doi:10.1080/10826076.2015.1076461

Cited by 7 publications

(2 citation statements)

References 42 publications

(6 reference statements)

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“…Reviewing the mobile phase systems used in the previously published TLC-densitometric methods which were developed for the determination of either HCZ with other drugs [ 34 – 40 ], HCZ with its impurities [ 41 – 43 ], or CPL in combination with other drugs [ 44 – 46 ], it was found that, in most manuscripts, methanol was used in combination with either ethyl acetate or chloroform. Chloroform was excluded for its toxic effect.…”

Section: Resultsmentioning

confidence: 99%

AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities

Nagieb,

Abdelwahab,

Abdelrahman

et al. 2024

BMC Chemistry

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Preserving the environment, reducing the amount of waste resulting from chemical trials, and reducing the amount of energy consumed have currently become a pivotal global trend. An analytical quality by design (AQbD) based eco-friendly TLC-densitometric method was implemented for quantifying two antihypertensive agents, captopril (CPL) and hydrochlorothiazide (HCZ), along with their impurities; captopril disulphide (CDS), chlorothiazide (CTZ) and salamide (SMD). The analytical target profile (ATP) was first identified, followed by selecting the critical analytical attributes (CAAs), such as retardation factors and resolution between the separated peaks. Critical method parameters (CMPs) that may have a crucial influence on CAAs were identified and emanated through the quality risk assessment phase. A literature survey-based preliminary studies were performed, followed by optimization of the selected CMPs through a custom experimental design to attain the highest resolution with optimum retardation factors. Moreover, method robustness was also tested by testing the design space. Complete separation of the drugs and their impurities was achieved using ethyl acetate: glacial acetic acid (6: 0.6, v/v) as a developing system applied to a 12 cm length TLC plate at room temperature with UV scanning at 215 nm. Calibration graphs were found to be linear in the ranges of (0.70–6.00), (0.10–2.00), (0.20–1.00), (0.07–1.50) and (0.05–1.00) µg/band corresponding to CPL, HCZ, CDS, CTZ, and SMD, respectively. Four different green metric tools were used to evaluate the greenness profile of the proposed method, and results showed that it is greener than the reported HPLC method. Method whiteness assessment was also conducted. Moreover, the method performance was evaluated following the ICH guidelines, and the outcomes fell within the acceptable limits. The developed method could be approved for routine assay of the cited components in their pharmaceutical formulations and bulk powder without interference from the reported impurities. The issue of concern is saving money, especially in developing countries.

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Section: Resultsmentioning

confidence: 99%

AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities

Nagieb,

Abdelwahab,

Abdelrahman

et al. 2024

BMC Chemistry

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“…Numerous analytical techniques have been established for the determination of CEL and AMLO alone or combined with other drugs as spectrophotometric [8][9][10][11], spectrofluorometric [12][13][14][15], high-performance thin-layer chromatography (HPTLC) [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30], HPLC [31][32][33], and electrochemical methods [34,35]. A few recently analytical techniques have been established for the simultaneous estimation of CEL and AMLO such as spectrophotometric [36], spectrofluorimetric [37], and HPLC [38,39].…”

Section: Introductionmentioning

confidence: 99%

Sensitive and validated TLC densitometry method coupled with fluorescence detection for quantitative determination of the newly co-formulated drugs, celecoxib and amlodipine besylate in tablet dosage form

Rizk

Toubar

Ramzy

et al. 2021

AChrom

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New, sensitive, rapid, cost-effective, and validated stability-indicating thin layer chromatographic (TLC) method coupled with fluorescence (FL) detection was developed for the quantitative analysis of celecoxib (CEL) and amlodipine besylate (AMLO) in their laboratory prepared binary mixture using the non-fluorescent TLC silica gel 60 plates. Ethyl acetate: diethylamine: 1-propanol (9:1:0.2, V/V) was used as a developing system. The retention factor (Rf) for each drug was 0.80 ± 0.03 and 0.44 ± 0.01 for CEL and AMLO, respectively. The plates were excited at 264 nm for the simultaneous FL measurement of CEL and AMLO, the calibration curves were linear over a concentration ranges of 30.0–300.0 ng/band and 15.0–150.0 ng/band with mean percentage recoveries of 99.80 ± 0.85 and 99.80 ± 0.77 For CEL and AMLO, respectively. The developed method was applied for the stability studies of the cited drugs in their laboratory prepared binary mixture and the forced degradation products were determined when present in presence of the pure drugs so the method can be considered as a stability-indicating one and it was validated as per ICH guidelines and proved to be accurate and precise.

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Facile separation of four co-formulated ternary antihypertensive drug combinations with a customized elution protocol using supercritical fluid chromatography

Pandya

Shah

Shrivastav

2020

Microchemical Journal

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HPTLC Method for Simultaneous Estimation of Aliskiren, Amlodipine, and Hydrochlorothiazide in Synthetic Mixture Using Quality by Design Approach

Cited by 7 publications

References 42 publications

AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities

AQbD TLC-densitometric method approach along with green fingerprint and whiteness assessment for quantifying two combined antihypertensive agents and their impurities

Sensitive and validated TLC densitometry method coupled with fluorescence detection for quantitative determination of the newly co-formulated drugs, celecoxib and amlodipine besylate in tablet dosage form

Facile separation of four co-formulated ternary antihypertensive drug combinations with a customized elution protocol using supercritical fluid chromatography

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