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Development of a Validated Comparative Stability-Indicating Assay Method for Some H2-Receptor Antagonists.
J Chromatogr Sci 2017; 55(8):818-831JC

Abstract

A comparative force degradation high performance thin layer chromatography (HPTLC) method was developed and validated for some H2-receptor antagonists. The studied H2-receptor antagonists were ranitidine (RAN), nizatidine (NIZ) and famotidine (FAM). The degradation behaviors of the studied H2-receptor antagonists were studied under different stress conditions (hydrolytic, thermal and oxidative) conditions as well as storage conditions according to International Conference on Harmonization (ICH) recommendations. A stability-indicating HPTLC method was optimized in order to separate the analyte from the degradation products formed under various stress conditions. Full separation of the drugs from their degradation products was successfully achieved on an HPTLC precoated silica gel plates. Densitometric measurements were carried out using a Camag TLC Scanner III in the absorbance mode at 320 nm for RAN and NIZ, and 280 nm for FAM. The limits of detection and limits of quantitation range were 5.47-9.37 and 16.30-31.26 ng/band, respectively, for all investigated drugs. The validation studies were performed according to ICH requirements. The developed method was simple, rapid and reliable hence it could be applied for routine quality control analysis of the investigated H2-receptor antagonists in dosage forms. The kinetic behavior, degradation rate constants and half-lives of the degradation of the investigated drugs were studied and compared at different stress conditions. The present study provides, for the first time, a new vision to compare the degradation kinetics of H2-receptor antagonists at the same degradation procedures.

Authors+Show Affiliations

Pharmacognosy and Pharmaceutical Chemistry Department, College of Pharmacy Taibah University, Al Madinah AlMunawarah 30001, Saudi Arabia. Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt.Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt.Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt. Department of Pharmaceutical Analytical Chemistry, Unaizah College of Pharmacy, Qassim University, Unaizah 5888, Saudi Arabia.Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28486578

Citation

Ahmed, Sameh, et al. "Development of a Validated Comparative Stability-Indicating Assay Method for some H2-Receptor Antagonists." Journal of Chromatographic Science, vol. 55, no. 8, 2017, pp. 818-831.
Ahmed S, Elshaboury SR, Mohamed NA, et al. Development of a Validated Comparative Stability-Indicating Assay Method for Some H2-Receptor Antagonists. J Chromatogr Sci. 2017;55(8):818-831.
Ahmed, S., Elshaboury, S. R., Mohamed, N. A., & Farrag, S. (2017). Development of a Validated Comparative Stability-Indicating Assay Method for Some H2-Receptor Antagonists. Journal of Chromatographic Science, 55(8), pp. 818-831. doi:10.1093/chromsci/bmx042.
Ahmed S, et al. Development of a Validated Comparative Stability-Indicating Assay Method for some H2-Receptor Antagonists. J Chromatogr Sci. 2017 Sep 1;55(8):818-831. PubMed PMID: 28486578.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of a Validated Comparative Stability-Indicating Assay Method for Some H2-Receptor Antagonists. AU - Ahmed,Sameh, AU - Elshaboury,Salwa R, AU - Mohamed,Niveen A, AU - Farrag,Shereen, PY - 2016/06/27/received PY - 2017/04/20/accepted PY - 2017/5/10/pubmed PY - 2018/3/27/medline PY - 2017/5/10/entrez SP - 818 EP - 831 JF - Journal of chromatographic science JO - J Chromatogr Sci VL - 55 IS - 8 N2 - A comparative force degradation high performance thin layer chromatography (HPTLC) method was developed and validated for some H2-receptor antagonists. The studied H2-receptor antagonists were ranitidine (RAN), nizatidine (NIZ) and famotidine (FAM). The degradation behaviors of the studied H2-receptor antagonists were studied under different stress conditions (hydrolytic, thermal and oxidative) conditions as well as storage conditions according to International Conference on Harmonization (ICH) recommendations. A stability-indicating HPTLC method was optimized in order to separate the analyte from the degradation products formed under various stress conditions. Full separation of the drugs from their degradation products was successfully achieved on an HPTLC precoated silica gel plates. Densitometric measurements were carried out using a Camag TLC Scanner III in the absorbance mode at 320 nm for RAN and NIZ, and 280 nm for FAM. The limits of detection and limits of quantitation range were 5.47-9.37 and 16.30-31.26 ng/band, respectively, for all investigated drugs. The validation studies were performed according to ICH requirements. The developed method was simple, rapid and reliable hence it could be applied for routine quality control analysis of the investigated H2-receptor antagonists in dosage forms. The kinetic behavior, degradation rate constants and half-lives of the degradation of the investigated drugs were studied and compared at different stress conditions. The present study provides, for the first time, a new vision to compare the degradation kinetics of H2-receptor antagonists at the same degradation procedures. SN - 1945-239X UR - https://www.unboundmedicine.com/medline/citation/28486578/Development_of_a_Validated_Comparative_Stability_Indicating_Assay_Method_for_Some_H2_Receptor_Antagonists_ L2 - https://academic.oup.com/chromsci/article-lookup/doi/10.1093/chromsci/bmx042 DB - PRIME DP - Unbound Medicine ER -