Simultaneous Estimation of Six Nitrosamine Impurities in Valsartan Using Liquid Chromatographic Method

Bodiwala, Kunjan B.; Panchal, Bhoomi G.; Savale, S. S; Dave, J. B.; Sureja, Dipen K.; Dhameliya, Tejas M.; Chhabria, Mahesh T.

doi:10.1093/jaoacint/qsab100

Cited by 6 publications

(4 citation statements)

References 13 publications

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“…The proposed method was evaluated on GAPI and AGREE metrics against recently reported UHPLC-MS [ 25 ] and HPLC-UV [ 30 ] methods. As shown in table 7 , the proposed method shows not only comparable, but even better ecological impact than the reported method.…”

Section: Resultsmentioning

confidence: 99%

“…Table 7. Evaluation of the greenness on GAPI and AGREE assessment tools for the proposed method, and reference methods [26,30].…”

Section: Comparison and Evaluation Against Other Reported Methodsmentioning

confidence: 99%

“…proposed green HPLC method reported method [26] reported method [30] technique green HPLC-UV UHPLC-MS RP-HPLC-UV mobile phase 0.02 M AMA adjusted to…”

Section: Comparison and Evaluation Against Other Reported Methodsmentioning

confidence: 99%

“…To our knowledge, only one article was reported recently for the determination of NDEA in VLS using conventional HPLC-UV [30]. However, the reported method did not consider the ecological aspects as it used a combination of ecologically hazardous reagents (formic acid, acetonitrile (ACN) royalsocietypublishing.org/journal/rsos R. Soc.…”

Section: Introductionmentioning

confidence: 99%

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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: Resultsmentioning

confidence: 99%

“…Table 7. Evaluation of the greenness on GAPI and AGREE assessment tools for the proposed method, and reference methods [26,30].…”

Section: Comparison and Evaluation Against Other Reported Methodsmentioning

confidence: 99%

“…proposed green HPLC method reported method [26] reported method [30] technique green HPLC-UV UHPLC-MS RP-HPLC-UV mobile phase 0.02 M AMA adjusted to…”

Section: Comparison and Evaluation Against Other Reported Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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