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Chromatographic Determination of Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride in the Presence of Their Potential Degradation Products.
J AOAC Int 2017; 100(2):434-444JA

Abstract

Two sensitive, selective, and precise stability-indicating methods have been developed for the simultaneous determination of the active pharmaceutical ingredients cyclopentolate hydrochloride (CLO) and phenylephrine hydrochloride (PHE) in their pure forms and in the presence of their degradation products. The methods were applied for the determination of CLO and PHE in a pharmaceutical formulation. Method A was based on isocratic elution HPLC determination. Separation was achieved using a Waters Spherisorb ODS2 C18 analytical column (5 μm particle size) and a mobile phase of 0.1% heptane-1-sulphonic acid sodium salt in methanol-water (80 + 20, v/v). The flow rate was 1.0 mL/min and detection was performed at 210 nm. Method B was an HPTLC- densitometric method using HPTLC silica gel 60 F254 plates and an optimized mobile phase of ethyl acetate-methanol-ammonia (8 + 2 + 0.1, v/v/v). The separated spots were densitometrically scanned at 210 nm. Polynomial equations were used for regression. The developed methods are suitable for the determination of CLO and PHE in their binary mixture and in the presence of their corresponding degradation products. The two methods were validated in compliance with International Conference on Harmonization guidelines and successfully applied for the determination of CLO and PHE as synthetically prepared in laboratory mixtures and in the presence of their possible degradation products. CLO alkaline degradation products were stated as potential impurities in British Pharmacopoeia. The degradation products were separated and identified by mass spectra. Postulation of a PHE oxidative degradation pathway was suggested. The obtained results were statistically analyzed and compared with those obtained by applying the official methods for both drugs.

Authors+Show Affiliations

Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, El- Kasr El-Aini St, 11562 Cairo, Egypt.Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, El- Kasr El-Aini St, 11562 Cairo, Egypt.Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, El- Kasr El-Aini St, 11562 Cairo, Egypt.Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, El- Kasr El-Aini St, 11562 Cairo, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28118561

Citation

Rezk, Mamdouh R., et al. "Chromatographic Determination of Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride in the Presence of Their Potential Degradation Products." Journal of AOAC International, vol. 100, no. 2, 2017, pp. 434-444.
Rezk MR, Fayed AS, Marzouk HM, et al. Chromatographic Determination of Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride in the Presence of Their Potential Degradation Products. J AOAC Int. 2017;100(2):434-444.
Rezk, M. R., Fayed, A. S., Marzouk, H. M., & Abbas, S. S. (2017). Chromatographic Determination of Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride in the Presence of Their Potential Degradation Products. Journal of AOAC International, 100(2), pp. 434-444. doi:10.5740/jaoacint.16-0215.
Rezk MR, et al. Chromatographic Determination of Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride in the Presence of Their Potential Degradation Products. J AOAC Int. 2017 Mar 1;100(2):434-444. PubMed PMID: 28118561.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Chromatographic Determination of Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride in the Presence of Their Potential Degradation Products. AU - Rezk,Mamdouh R, AU - Fayed,Ahmed S, AU - Marzouk,Hoda M, AU - Abbas,Samah S, Y1 - 2016/11/30/ PY - 2017/1/25/pubmed PY - 2017/6/7/medline PY - 2017/1/25/entrez SP - 434 EP - 444 JF - Journal of AOAC International JO - J AOAC Int VL - 100 IS - 2 N2 - Two sensitive, selective, and precise stability-indicating methods have been developed for the simultaneous determination of the active pharmaceutical ingredients cyclopentolate hydrochloride (CLO) and phenylephrine hydrochloride (PHE) in their pure forms and in the presence of their degradation products. The methods were applied for the determination of CLO and PHE in a pharmaceutical formulation. Method A was based on isocratic elution HPLC determination. Separation was achieved using a Waters Spherisorb ODS2 C18 analytical column (5 μm particle size) and a mobile phase of 0.1% heptane-1-sulphonic acid sodium salt in methanol-water (80 + 20, v/v). The flow rate was 1.0 mL/min and detection was performed at 210 nm. Method B was an HPTLC- densitometric method using HPTLC silica gel 60 F254 plates and an optimized mobile phase of ethyl acetate-methanol-ammonia (8 + 2 + 0.1, v/v/v). The separated spots were densitometrically scanned at 210 nm. Polynomial equations were used for regression. The developed methods are suitable for the determination of CLO and PHE in their binary mixture and in the presence of their corresponding degradation products. The two methods were validated in compliance with International Conference on Harmonization guidelines and successfully applied for the determination of CLO and PHE as synthetically prepared in laboratory mixtures and in the presence of their possible degradation products. CLO alkaline degradation products were stated as potential impurities in British Pharmacopoeia. The degradation products were separated and identified by mass spectra. Postulation of a PHE oxidative degradation pathway was suggested. The obtained results were statistically analyzed and compared with those obtained by applying the official methods for both drugs. SN - 1944-7922 UR - https://www.unboundmedicine.com/medline/citation/28118561/Chromatographic_Determination_of_Cyclopentolate_Hydrochloride_and_Phenylephrine_Hydrochloride_in_the_Presence_of_Their_Potential_Degradation_Products_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1060-3271&volume=100&issue=2&spage=434&aulast=Rezk DB - PRIME DP - Unbound Medicine ER -