A validated new RP-HPLC method for simultaneous determination of amoxicillin, ampicillin and cloxacillin in pharmaceutical formulations

• Autorzy: Gebretsadik Hailekiros , Kahsay Getu , Eticha Tadele , Gebretsadikan Tesfamichael

Identyfikatory

DOI

10.1556/1326.2022.01043

• Języki publikacji: EN

Abstrakty

EN

As per the World Health Organization, 10% of medicines in low- and middle-income nations are of poor quality and pose a huge public health risk. The development and implementation of cost-effective, efficient and quick analytical methods to control the quality of these medicines is one of the immediate strategies to avoid such a situation. Hence, the main goal of this study was to develop and validate a simple, specific and precise new RP–HPLC method for simultaneous analysis of amoxicillin, ampicillin and cloxacillin in pharmaceutical formulations. The chromatographic analysis was achieved using Shodex C₁₈ (250 × 4.6 mm, 5 μm) column with UV detection at 225 nm. The mobile phase was a gradient mixture of 30 mM phosphate buffer, pH 4.0 (mobile phase A) and acetonitrile (mobile phase B). Efficient separation of the three drugs was obtained using the final optimized chromatographic conditions. The developed method was validated for its specificity, linearity, precision, accuracy and robustness as per the ICH guidelines. The validation results showed that the method was specific, linear, precise, accurate and robust for the simultaneous determination of the three drugs. The developed method was applied to determine the content of the three drugs in pharmaceutical formulations. The assay results of the preparations showed that their drug content was within the pharmacopeial limit stipulated for each drug product. It can be concluded that the proposed method is suitable for simultaneous determination of amoxicillin, ampicillin and cloxacillin in pharmaceutical formulations in industries and regulatory laboratories.

Słowa kluczowe

EN

amoxicillin; ampicillin; cloxacillin; RP-HPLC; method development

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2023
• Tom: Vol. 35, no. 2
• Strony: 193--203
• Opis fizyczny: Bibliogr. 26 poz., rys., tab., wykr.

Twórcy

autor

Gebretsadik Hailekiros

• Department of Pharmaceutical Analysis & Quality Assurance, School of Pharmacy, College of Health Sciences, Mekelle University, P.O.Box 1871, Mekelle, Ethiopia

autor

Kahsay Getu

• Department of Pharmaceutical Analysis & Quality Assurance, School of Pharmacy, College of Health Sciences, Mekelle University, P.O.Box 1871, Mekelle, Ethiopia

• https://orcid.org/0000-0002-5192-1358

autor

Eticha Tadele

• Department of Pharmaceutical Chemistry & Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box 1176, Addis Ababa, Ethiopia

autor

Gebretsadikan Tesfamichael

• Department of Pharmaceutical Analysis & Quality Assurance, School of Pharmacy, College of Health Sciences, Mekelle University, P.O.Box 1871, Mekelle, Ethiopia

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