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

Pandya, Pranav A.; Shah, Priyanka A.; Shrivastav, Pranav S.

doi:10.1016/j.microc.2020.105594

Cited by 8 publications

(8 citation statements)

References 38 publications

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“…Although LOS and VLS were studied, in a dense way, alone or in combinations with other drugs using different analytical techniques [2,[12][13][14][15][16][17], few literatures were reported for their determination with nitrosamine impurities. Determination of VLS and LOS with NDEA either alone or together was reported mainly using GC or LC with MS/MS detectors [18][19][20][21][22][23][24][25][26][27].…”

Section: Introductionmentioning

confidence: 99%

Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

et al. 2022

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Angiotensin-converting enzyme inhibitors are one of the most widely used anti-hypertensive drugs which are used to reduce hypertension. In 2018, the United States Food and Drug Administration together with the European Medicine Agency declared the presence of carcinogenic nitrosamine impurities such as nitrosodiethylamine (NDEA) in some of the products, including valsartan (VLS) and losartan (LOS), and drugs' recall procedures were started. Thus, they should be controlled to be below the acceptable cancer risk level to ensure safety of the pharmaceutical products. Therefore, sensitive and reliable analytical methods were required for detection and quantitation of NDEA in bulk and finished drug products. Green analytical chemistry has received great interest to minimize the amount of organic solvents consumed without loss in chromatographic performance. A green and sensitive HPLC method was developed for the determination of NDEA in LOS and VLS using mobile phase of 0.02 M ammonium acetate adjusted to pH 7.2 and ethanol in gradient manner. Limits of detection and limits of quantification for NDEA were estimated to be 0.2 and 0.5 µg ml −1 , respectively. The standardized limits of NDEA impurity in drug substances were set as 0.56 ppm, which indicates the feasibility of its determination by the proposed conventional method without need for expensive instrumentations (e.g. MS/MS detectors) that are not found in most pharmaceutical quality control laboratories.

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Section: Introductionmentioning

confidence: 99%

Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

et al. 2022

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“…The polymeric pyridyl group is covalently attached to the silica shielding residual silanol groups [227] and can be reversibly tuned to the cationic pyridinium form via an organic modifier containing trifluoroacetic acid [227]. The poly(4-vinylpyridine) stationary phase was successfully used for the separation of PAH [227], steroids [227], and anti-hypertensive drugs [228,229].…”

Section: Unconventional Stationary Phases In Sfcmentioning

confidence: 99%

Columns in analytical‐scale supercritical fluid chromatography: From traditional to unconventional chemistries

Plachká

Pilařová

Horáček

et al. 2023

J of Separation Science

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Within this review, we thoroughly explored supercritical fluid chromatography (SFC) columns used across > 3000 papers published from the first study carried out under SFC conditions in 1962 to the end of 2022. We focused on the open tubular capillary, packed capillary, and packed columns, their chemistries, dimensions, and trends in used stationary phases with correlation to their specific interactions, advantages, drawbacks, used instrumentation, and application field. Since the 1990s, packed columns with liquid chromatography and SFC‐dedicated stationary phases for chiral and achiral separation are predominantly used. These stationary phases are based on silica support modified with a wide range of chemical moieties. Moreover, numerous unconventional stationary phases were evaluated, including porous graphitic carbon, titania, zirconia, alumina, liquid crystals, and ionic liquids. The applications of unconventional stationary phases are described in detail as they bring essential findings required for further development of the supercritical fluid chromatography technique.

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“…Fast or ultrafast separations have often been linked to the use of SFC, and analysis times in the order of minutes or even seconds 41 are indeed achievable 5,42–45 . In most cases, the SFC‐based approach yields higher throughput than LC‐based approaches 46 .…”

Section: Supercritical Fluid Chromatographymentioning

confidence: 99%

Recent advances in analytical techniques for high throughput experimentation

Vervoort

Goossens

Baeten

et al. 2021

Analytical Science Advances

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High throughput experimentation is a growing and evolving field that allows to execute dozens to several thousands of experiments per day with relatively limited resources. Through miniaturization, typically a high degree of automation and the use of digital data tools, many parallel reactions or experiments at a time can be run in such workflows. High throughput experimentation also requires fast analytical techniques capable of generating critically important analytical data in line with the increased rate of experimentation. As traditional techniques usually do not deliver the speed required, some unique approaches are required to enable workflows to function as designed. This review covers the recent developments (2019‐2020) in this field and was intended to give a comprehensive overview of the current “state‐of‐the‐art.”

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

Cited by 8 publications

References 38 publications

Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

Columns in analytical‐scale supercritical fluid chromatography: From traditional to unconventional chemistries

Recent advances in analytical techniques for high throughput experimentation

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