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Validated liquid chromatographic determination of a novel ACE inhibitor in the presence of its hydrolytic and oxidative degradation products as per ICH guidelines.
Talanta 2014; 119:170-7T

Abstract

Imidapril hydrochloride (IMD) is a recently developed prodrug-type angiotensin-converting enzyme (ACE) inhibitor. Due to its instability under both hydrolytic and oxidative conditions, development of rapid, simple and sensitive methods for its determination in the presence of its possible degradation products is essential. We proposed two simple liquid chromatographic methods associated with ultraviolet detection. The first method is an HPTLC-densitometric one in which separation of IMD from its degradation products was achieved followed by densitometric scanning at 220 nm using silica gel F254 plates and chloroform:ethanol:acetic acid (3:0.5:0.1, v/v/v) as the developing system. The second method was based on RP-HPLC in which the separation was performed using C18 analytical column and isocratic elution system with acetonitrile: 0.15% triethylamine (pH=2.2) (40:60, v/v). The optimum flow rate was 1.5 mL min(-1) and the detection was at 220 nm. Validation was conducted in compliance with the ICH guidelines and the methods were successfully applied for IMD determination in its commercial tablets. The obtained results were statistically compared to those obtained by applying reported HPLC method where no significant difference was found in accordance with accuracy and precision.

Authors+Show Affiliations

Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Cairo, Egypt. Electronic address: mahahgazy@yahoo.com.Department of Analytical Chemistry, Faculty of Pharmacy, Egyptian Russian University, Cairo, Egypt.National Organization of Drug Control and Research (NODCAR), Giza, Egypt.Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

24401400

Citation

Hegazy, Maha A., et al. "Validated Liquid Chromatographic Determination of a Novel ACE Inhibitor in the Presence of Its Hydrolytic and Oxidative Degradation Products as Per ICH Guidelines." Talanta, vol. 119, 2014, pp. 170-7.
Hegazy MA, Eissa MS, Abd El-Sattar OI, et al. Validated liquid chromatographic determination of a novel ACE inhibitor in the presence of its hydrolytic and oxidative degradation products as per ICH guidelines. Talanta. 2014;119:170-7.
Hegazy, M. A., Eissa, M. S., Abd El-Sattar, O. I., & Abd El-Kawy, M. M. (2014). Validated liquid chromatographic determination of a novel ACE inhibitor in the presence of its hydrolytic and oxidative degradation products as per ICH guidelines. Talanta, 119, pp. 170-7. doi:10.1016/j.talanta.2013.10.022.
Hegazy MA, et al. Validated Liquid Chromatographic Determination of a Novel ACE Inhibitor in the Presence of Its Hydrolytic and Oxidative Degradation Products as Per ICH Guidelines. Talanta. 2014;119:170-7. PubMed PMID: 24401400.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validated liquid chromatographic determination of a novel ACE inhibitor in the presence of its hydrolytic and oxidative degradation products as per ICH guidelines. AU - Hegazy,Maha A, AU - Eissa,Maya S, AU - Abd El-Sattar,Osama I, AU - Abd El-Kawy,Mohamed M, Y1 - 2013/11/08/ PY - 2013/05/07/received PY - 2013/10/15/revised PY - 2013/10/16/accepted PY - 2014/1/10/entrez PY - 2014/1/10/pubmed PY - 2014/9/3/medline KW - AKN KW - DKP KW - Degradation products KW - ES KW - HPLC KW - HPTLC KW - IMD KW - Imidapril hydrochloride KW - OXI KW - Stability-indicating method KW - diketopiprazine KW - external standard KW - imidapril hydrochloride KW - suggested alkaline induced degradation product of imidapril hydrochloride KW - suggested oxidative induced degradation product of imidapril hydrochloride SP - 170 EP - 7 JF - Talanta JO - Talanta VL - 119 N2 - Imidapril hydrochloride (IMD) is a recently developed prodrug-type angiotensin-converting enzyme (ACE) inhibitor. Due to its instability under both hydrolytic and oxidative conditions, development of rapid, simple and sensitive methods for its determination in the presence of its possible degradation products is essential. We proposed two simple liquid chromatographic methods associated with ultraviolet detection. The first method is an HPTLC-densitometric one in which separation of IMD from its degradation products was achieved followed by densitometric scanning at 220 nm using silica gel F254 plates and chloroform:ethanol:acetic acid (3:0.5:0.1, v/v/v) as the developing system. The second method was based on RP-HPLC in which the separation was performed using C18 analytical column and isocratic elution system with acetonitrile: 0.15% triethylamine (pH=2.2) (40:60, v/v). The optimum flow rate was 1.5 mL min(-1) and the detection was at 220 nm. Validation was conducted in compliance with the ICH guidelines and the methods were successfully applied for IMD determination in its commercial tablets. The obtained results were statistically compared to those obtained by applying reported HPLC method where no significant difference was found in accordance with accuracy and precision. SN - 1873-3573 UR - https://www.unboundmedicine.com/medline/citation/24401400/Validated_liquid_chromatographic_determination_of_a_novel_ACE_inhibitor_in_the_presence_of_its_hydrolytic_and_oxidative_degradation_products_as_per_ICH_guidelines_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0039-9140(13)00821-7 DB - PRIME DP - Unbound Medicine ER -