Development and validation of eco-friendly micellar HPLC method for the simultaneous determination of hydrochlorothiazide and valsartan in bulk powder and pharmaceutical dosage forms

Ayad, Magda M.; Hosny, Mervat M.; Ibrahim, Adel Ehab; El-Abassy, Omar M.; Belal, Fathalla

doi:10.1007/s13738-020-01897-z

Cited by 8 publications

(3 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Organic modifier was chosen according to its ecological impact. ACN although having unique separation characteristics, its ecological impact is high, besides its higher cost [ 34 ]. EtOH on the other hand had comparable efficiency, yet at lower ecological impact [ 35 ].…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2022

Self Cite

View full text Add to dashboard Cite

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.

show abstract

Section: Resultsmentioning

confidence: 99%

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

et al. 2022

Self Cite

View full text Add to dashboard Cite

show abstract

“…Isocratic elution using mobile phase composed of 50 mM potassium dihydrogen phosphate buffer pH 2. enabled the use of isopropanol instead of toxic organic solvent such as acetonitrile, which is more environmentally friendly, and also decreased the ratio required to improve elution to only 7.5% (v/v). 37 Other reported methods have 3 and 6 red-colored pentograms. 5,9 Compared to the stability indicating method 5 , our method has advantages in terms of greenness and also in terms of analysis time.…”

Section: Gapimentioning

confidence: 99%

Micellar Liquid Chromatographic Method for Determination of Moxifloxacin and its Impurities

Salkić,

Otašević,

Rašević

et al. 2023

ACSi

View full text Add to dashboard Cite

A selective eco-friendly micellar HPLC method was developed for investigation of moxifloxacin and related compounds in the presence of its degradation products. Central composite design was used to optimize the experimental conditions. The proposed method is based on isocratic elution on a C18 column using 92.5% (v/v) biodegradable aqueous mobile phase containing 0.01 M sodium dihydrogen phosphate, 0.15 M sodium dodecyl sulfate (SDS) and 0.5% triethylamine (v/v) with a pH of 3.5 and 7.5% isopropanol (v/v) as eco- friendly organic solvent. The flow rate and injection volume were 0.6 ml/min and 5 μl, respectively. Experiments were performed at a temperature of 60 °C and detection was performed at 295 nm. The optimized method was validated. The method was found to be suitable for the quantification of moxifloxacin and its related compounds in moxifloxacin drug substance. The Green Analytical Procedure Index (GAPI) proves the superiority of the developed method against other reported methods.

show abstract

“…Surfactants in micellar mobile phases modify stationary phases by masking silanol groups that in turn resulted in improving the peak shape. Surfactants had been applied in determination of drug mixtures when mixed with a small proportion of organic solvent [3][4][5][6][7], applied as green extraction technique [8,9], or sometimes applied as stationary phase replacement (pseudo-phase) [10,11].…”

Section: Introductionmentioning

confidence: 99%

Solvent‐free mixed micellar mobile phases: An advanced green chemistry approach for reversed‐phase HPLC determination of some antihypertensive drugs

Ibrahim

Elmansi

Belal

2020

J of Separation Science

Self Cite

View full text Add to dashboard Cite

Minimizing the amount of organic solvents without loss in chromatographic performance has been an important step toward greening analytical methodologies. Mobile‐phase composition is the key for maintaining separation efficiency in liquid chromatography while decreasing the procedure hazardousness. If sodium dodecyl sulfate is mixed with Brij‐35 in the mobile phase, they could be used as a green alternative for using organic modifiers. In this research, the effect of changing the relative amounts of both surfactants was studied on the chromatographic performance and separation efficiency of ten antihypertensive drugs belonging to different categories. The use of surfactants has many advantages including low cost and toxicity, safe environmental disposal, unique selectivity besides high solubilization capabilities. The optimum separation was maintained using a mobile phase (0.01 M Brij‐35, 0.08 M sodium dodecyl sulfate and 0.01 M sodium dihydrogen phosphate/pH 5) on reversed‐phase C18 core–shell column at flow rate 1.5 mL/min and temperature 30°C. The method was successfully applied for the determination of the drugs in various marketed dosage forms. International Conference of Harmonization guidelines were followed to validate the developed method. Additionally, the method was verified on the Green Analytical Procedure Index in regards to the greenness and found to be an excellent green alternative method.

show abstract

Development and validation of eco-friendly micellar HPLC method for the simultaneous determination of hydrochlorothiazide and valsartan in bulk powder and pharmaceutical dosage forms

Cited by 8 publications

References 21 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

Micellar Liquid Chromatographic Method for Determination of Moxifloxacin and its Impurities

Solvent‐free mixed micellar mobile phases: An advanced green chemistry approach for reversed‐phase HPLC determination of some antihypertensive drugs

Contact Info

Product

Resources

About