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.
| العنوان: | A stability indicating RP-HPLC-UV assay method for the simultaneous determination of hydroquinone, tretinoin, hydrocortisone, butylated hydroxytoluene and parabens in pharmaceutical creams. |
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| المؤلفون: | Khairy MA; Research and Development, Glopal Napi Pharmaceuticals, 6th October City, Giza 12511, Egypt., Hamad A; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Menoufia University, Shebin El-Koum 32511, Egypt., Hamed M; Pharmaceutical Chemistry Department, Faculty of Pharmacy, Misr International University, Km 28 Ismailia Road, Cairo 44971, Egypt., Locatelli M; Department of Pharmacy, University 'G. d'Annunzio' of Chieti-Pescara, Chieti 66100, Italy. Electronic address: marcello.locatelli@unich.it., Mansour FR; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Tanta University, Tanta 31111, Egypt. Electronic address: fotouhrashed@pharm.tanta.edu.eg. |
| المصدر: | Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 May 15; Vol. 242, pp. 116021. Date of Electronic Publication: 2024 Feb 08. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Country of Publication: England NLM ID: 8309336 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-264X (Electronic) Linking ISSN: 07317085 NLM ISO Abbreviation: J Pharm Biomed Anal Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2006->: London : Elsevier Science Original Publication: Oxford ; New York : Pergamon Press, c1983- |
| مواضيع طبية MeSH: | Parabens*/analysis , Tretinoin*/analysis, Humans ; Hydrocortisone/analysis ; Butylated Hydroxytoluene ; Excipients ; Chromatography, High Pressure Liquid/methods ; Hydroquinones/analysis |
| مستخلص: | 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 (130%). Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.) |
| فهرسة مساهمة: | Keywords: AGREEprep and BAGI; Hydroquinone; Parabens; RP-HPLC; Stability study; Topical Formulations |
| المشرفين على المادة: | A2I8C7HI9T (methylparaben) Z8IX2SC1OH (propylparaben) 0 (Parabens) 5688UTC01R (Tretinoin) WI4X0X7BPJ (Hydrocortisone) 1P9D0Z171K (Butylated Hydroxytoluene) 0 (Excipients) XV74C1N1AE (hydroquinone) 0 (Hydroquinones) |
| تواريخ الأحداث: | Date Created: 20240214 Date Completed: 20240312 Latest Revision: 20240312 |
| رمز التحديث: | 20240312 |
| DOI: | 10.1016/j.jpba.2024.116021 |
| PMID: | 38354540 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1873-264X |
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| DOI: | 10.1016/j.jpba.2024.116021 |