دورية أكاديمية

A stability indicating RP-HPLC-UV assay method for the simultaneous determination of hydroquinone, tretinoin, hydrocortisone, butylated hydroxytoluene and parabens in pharmaceutical creams

التفاصيل البيبلوغرافية
العنوان: A stability indicating RP-HPLC-UV assay method for the simultaneous determination of hydroquinone, tretinoin, hydrocortisone, butylated hydroxytoluene and parabens in pharmaceutical creams
المؤلفون: Mostafa A. Khairy, Amal Hamad, Mahmoud Hamed, Marcello Locatelli, Fotouh R. Mansour
المساهمون: Khairy, Mostafa A., Hamad, Amal, Hamed, Mahmoud, Locatelli, Marcello, Mansour, Fotouh R.
سنة النشر: 2024
المجموعة: ARUd'A - Archivio Istituzionale della ricerca dell'università Chieti-Pescara (IRIS)
مصطلحات موضوعية: RP-HPLC, Hydroquinone, Paraben, Topical Formulation, AGREEprep and BAGI, Stability study
الوصف: Multicomponent drugs are medications that combine two or more active pharmaceutical ingredients in a single dosage form. These dosage forms improve the patient compliance, reduce the risk of drug interactions, and simplify dosing regimens. However, quality control of these multicomponent dosage forms can be challenging, especially if the final product contains four or more ingredients that are active (comprise stabilizers, preservatives, excipients, and other components). This problem can be more pronounced if the excipients can interfere with the analysis. In this work, a stability indicating assay method was developed and validated (according to the ICH International Guidelines) for the simultaneous determination of hydroquinone (HQ), tretinoin (TRT), hydrocortisone (HCA), butylated hydroxytoluene (BHT), methyl paraben (MP) and propyl paraben (PP) in commercially available pharmaceutical creams. The proposed method is based on gradient elution using X-Bridge C18 (150 × 4.6 mm, 5 μm) column with a flow rate of 1 mL/min. The linear ranges (μg/mL) were 240-560 for HQ, 24-56 for MP, 132-308 for HCA, 6-14 for PP, 12-28 for BHT, 6.6-15 for TRT. During the validation process, the intra- and interday precision and trueness (evaluated as recovery) were found to be below 2.0% and between 100-102%, respectively. System suitability tests (SST) allow validating the herein proposed procedure specifically for pharmaceutical and industrial applications. SST test shows that the reported procedure fulfill with the Guidelines, allowing excellent separation of the analytes with very sensitive, accurate (precise and true) and reproducible quantitation of each analytes. The method was successfully applied in forced degradation studies of the six analytes. Specifically, acid degradation slightly affected HCA and BHT (91% recovery), while alkaline degradation drastically reduced HCA recovery (5.5%) and moderately affected BHT (85%). Photodegradation primarily influenced TRT quantity, and oxidative degradation intensified the BHT peak ...
نوع الوثيقة: article in journal/newspaper
وصف الملف: ELETTRONICO
اللغة: English
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/38354540; volume:242; firstpage:116021; journal:JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS; https://hdl.handle.net/11564/825011Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85184913534; https://www.sciencedirect.com/science/article/pii/S073170852400061XTest
DOI: 10.1016/j.jpba.2024.116021
الإتاحة: https://doi.org/10.1016/j.jpba.2024.116021Test
https://hdl.handle.net/11564/825011Test
https://www.sciencedirect.com/science/article/pii/S073170852400061XTest
حقوق: info:eu-repo/semantics/openAccess
رقم الانضمام: edsbas.941544B7
قاعدة البيانات: BASE