Development and validation of high-performance thin layer chromatographic method for simultaneous quantitation of novel combination perindopril erbumine and moxonidine hydrochloride

被引:5
|
作者
Akabari, Ashok H. [1 ,3 ]
Surati, Jasmina [1 ]
Patel, Sagar [1 ]
Pathak, Bhumin [1 ]
Patel, Arun [1 ]
Patel, Chandani [1 ]
Patel, Sagarkumar K. [2 ]
机构
[1] Shree Naranjibhai Lalbhai Patel Coll Pharm, Dept Qual Assurance, Umrakh, Gujarat, India
[2] Labcorp Drug Dev Inc, Somerset, NJ USA
[3] Shree Naranjibhai Lalbhai Patel Coll Pharm, Umrakh, Gujarat, India
关键词
analytical method; anti-hypertensive agent; high-performance thin-layer chromatography method; moxonidine hydrochloride; perindopril erbumine; HUMAN PLASMA; AMLODIPINE; ARGININE; BULK;
D O I
10.1002/sscp.202300051
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
The primary purpose of the present study was to develop and validate a high-performance thin-layer chromatography method for quantitatively determining an anti-hypertensive agent, perindopril erbumine, and moxonidine hydrochloride in bulk and synthetic mixture. The densitometric procedure was performed on aluminum thin-layer chromatography plates pre-coated with silica gel 60F254, employing a combination of dichloromethane: toluene: methanol: ammonia (7:1:2:0.1 v/v/v/v) as the mobile phase. The thin-layer chromatography scanner was operated in absorbance mode at a wavelength of 223 nm to evaluate densitograms. The linearity of the method was established in the range of 1000-5000 ng/band for perindopril erbumine and 40-200 ng/band for moxonidine hydrochloride; the correlation coefficient (r(2)) was 0.9993 and 0.9983, respectively. The values of a limit of detection (186.06 and 3.51 ng/band, respectively, for perindopril erbumine and moxonidine hydrochloride) and limit of quantification (620.23 and 11.73 ng/band, respectively, for perindopril erbumine and moxonidine hydrochloride) have demonstrated the sensitivity of the developed method. The reported process was precise in both intra-day and inter-day analysis; the percentage relative standard deviation of peak area was less than 2% and has an accuracy within 100 +/- 2%. The developed method has the potential to quantify perindopril erbumine and moxonidine hydrochloride from its synthetic mixture without any interference from other components or in quality control laboratories.
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页数:9
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