Affiliation:
1. NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
2. Zhejiang University of Technology, Hangzhou 310014, China
Abstract
Abstract
Background
Losartan potassium, a common antihypertensive drug on the market, has multiple polymorphs, of which form I is used as a pharmaceutical crystal form. Form I can be partially converted to form III under some circumstances. The quantification of losartan potassium polymorphs is important to control the quality of pharmaceuticals.
Objective
To establish a method to determine the contents of losartan potassium polymorphs.
Methods
Pure form I and form III of losartan potassium were obtained by recrystallization, and characterized by powder X-ray diffraction (PXRD), Fourier transform infrared spectroscopy, Raman spectroscopy, and thermal analysis. A powder X-ray diffraction method was developed to characterize form I and form III of losartan potassium. Peak area and weight percentage were used to establish calibration curve.
Results
The calibration curve was linear over the range of 1–50% (w/w), using the characteristic peak area ratio of form I at 11.13° 2θ and form III at 5.64° 2θ as the quantitative parameter. The precisions were excellent between 0.6–4.9%, and the limit of quantification was 2.02% (w/w).
Conclusions
This PXRD method can be used to analyze mixtures of losartan potassium polymorphs (forms I and III) quantitatively and control the quality of bulk drug.
Highlights
This is a new method of quantifying the amount of form III in polymorphic forms of losartan potassium using data obtained by PXRD. It is consistent, sensitive, and accurate.
Publisher
Oxford University Press (OUP)
Subject
Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry
Cited by
2 articles.
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