Tags

Type your tag names separated by a space and hit enter

Validated chromatographic methods for determination of perindopril and amlodipine in pharmaceutical formulation in the presence of their degradation products.
J Chromatogr Sci 2013; 51(6):533-43JC

Abstract

Two specific, sensitive, and precise stability-indicating chromatographic methods have been developed, optimized and validated for determination of perindopril arginin (PER) and amlodipine besylate (AML) in their mixtures and in the presence of their degradation products. The first method was based on thin-layer chromatography (TLC) combined with densitometric determination of the separated bands. Adequate separation was achieved using silica gel 60 F254 TLC plates and ethyl acetate-methanol-toluene-ammonia solution, 33% (6.5:2:1:0.5 by volume), as a developing system. The second method was based on high-performance liquid chromatography, by which the proposed components were separated on a reversed-phase C18 analytical column using a mobile phase consisting of phosphate buffer (pH 2.5, 0.01 M)-acetonitrile-tetrahydrofuran (60:40:0.1% by volume) with ultraviolet detection at 218 nm. Different parameters affecting the suggested methods were optimized for maximum separation of the cited components. System suitability parameters of the two developed methods were also tested. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the quantification of PER and AML in their commercial tablets. Both methods were also statistically compared to each other and to the reference methods with no significant differences in performance.

Authors+Show Affiliations

Analytical Chemistry Department, Faculty of Pharmacy-Cairo University, Kasr El-Aini Street,11562 Cairo, Egypt.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23112269

Citation

Zaazaa, Hala E., et al. "Validated Chromatographic Methods for Determination of Perindopril and Amlodipine in Pharmaceutical Formulation in the Presence of Their Degradation Products." Journal of Chromatographic Science, vol. 51, no. 6, 2013, pp. 533-43.
Zaazaa HE, Abbas SS, Essam HA, et al. Validated chromatographic methods for determination of perindopril and amlodipine in pharmaceutical formulation in the presence of their degradation products. J Chromatogr Sci. 2013;51(6):533-43.
Zaazaa, H. E., Abbas, S. S., Essam, H. A., & El-Bardicy, M. G. (2013). Validated chromatographic methods for determination of perindopril and amlodipine in pharmaceutical formulation in the presence of their degradation products. Journal of Chromatographic Science, 51(6), pp. 533-43. doi:10.1093/chromsci/bms171.
Zaazaa HE, et al. Validated Chromatographic Methods for Determination of Perindopril and Amlodipine in Pharmaceutical Formulation in the Presence of Their Degradation Products. J Chromatogr Sci. 2013;51(6):533-43. PubMed PMID: 23112269.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validated chromatographic methods for determination of perindopril and amlodipine in pharmaceutical formulation in the presence of their degradation products. AU - Zaazaa,Hala E, AU - Abbas,Samah S, AU - Essam,Hebat Allah M, AU - El-Bardicy,Mohammed G, Y1 - 2012/10/30/ PY - 2012/11/1/entrez PY - 2012/11/1/pubmed PY - 2013/12/18/medline SP - 533 EP - 43 JF - Journal of chromatographic science JO - J Chromatogr Sci VL - 51 IS - 6 N2 - Two specific, sensitive, and precise stability-indicating chromatographic methods have been developed, optimized and validated for determination of perindopril arginin (PER) and amlodipine besylate (AML) in their mixtures and in the presence of their degradation products. The first method was based on thin-layer chromatography (TLC) combined with densitometric determination of the separated bands. Adequate separation was achieved using silica gel 60 F254 TLC plates and ethyl acetate-methanol-toluene-ammonia solution, 33% (6.5:2:1:0.5 by volume), as a developing system. The second method was based on high-performance liquid chromatography, by which the proposed components were separated on a reversed-phase C18 analytical column using a mobile phase consisting of phosphate buffer (pH 2.5, 0.01 M)-acetonitrile-tetrahydrofuran (60:40:0.1% by volume) with ultraviolet detection at 218 nm. Different parameters affecting the suggested methods were optimized for maximum separation of the cited components. System suitability parameters of the two developed methods were also tested. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the quantification of PER and AML in their commercial tablets. Both methods were also statistically compared to each other and to the reference methods with no significant differences in performance. SN - 1945-239X UR - https://www.unboundmedicine.com/medline/citation/23112269/Validated_chromatographic_methods_for_determination_of_perindopril_and_amlodipine_in_pharmaceutical_formulation_in_the_presence_of_their_degradation_products_ L2 - https://academic.oup.com/chromsci/article-lookup/doi/10.1093/chromsci/bms171 DB - PRIME DP - Unbound Medicine ER -