Analytical quality by design approach for the control of potentially counterfeit chloroquine with some NSAIDS using HPLC with fluorescence detection in pharmaceutical preparation and breast milk

Hassan, Said A.; Ibrahim, Noha; Elzanfaly, Eman S.; El Gendy, Ahmed E.

doi:10.1556/1326.2020.00793

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Tytuł artykułu

Analytical quality by design approach for the control of potentially counterfeit chloroquine with some NSAIDS using HPLC with fluorescence detection in pharmaceutical preparation and breast milk

Autorzy

Hassan Said A. , Ibrahim Noha , Elzanfaly Eman S. , El Gendy Ahmed E.

Wybrane pełne teksty z tego czasopisma

Identyfikatory

DOI

10.1556/1326.2020.00793

Warianty tytułu

Języki publikacji

Abstrakty

Chloroquine phosphate (CQ) the antimalarial drug and suggested to treat the pandemic disease coronavirus (COVID-19) is often adulterated with some of the non-steroidal anti-inflammatory drugs (NSAIDs) such as paracetamol, aspirin (ASP), or both. The purpose of this study is to detect such counterfeited drugs, using a reversed phase high pressure liquid chromatography (RP-HPLC) method with fluorescence detection. Analysis was divided into three phases. In the first phase, a Plackett-Burman design (PBD) was used to screen five independent factors, namely, buffer pH, buffer concentration (mM), acetonitrile content (%), flow rate (mL/min) and triethylamine (TEA) content in the buffer preparation (%). The selected dependent variables were (resolution, symmetry of peaks and run time). The objective of the second phase was to optimize the method performance using Box-Behnken design (BBD) and desirability function for multiple response optimization to obtain the best chromatographic performance with the shortest run time. Optimal chromatographic separation was achieved on a YMC-pack pro C18 ODS-A column (15 cm × 4.6 mm, 5 µm) at room temperature The optimum mobile phase consisted of acetonitrile and 5 mM sodium dihydrogen phosphate buffer containing 0.5% triethyamine (30:70, v/v) with the pH adjusted to 3.5 using an orthophosphoric acid solution. The flow rate was maintained at 1 mL/min, and the detection was performed with a fluorescence detector fixed at 380 nm_(λemission) after excitation at 335 nm_{(λexcitation)}. The third phase was method validation according to ICH guidelines, providing to be specific, precise, accurate, and robust. The method is linear over a range of 0.4–8 µg/mL for chloroquine and ASP, while for paracetamol it is linear over 16–48 µg/mL. The developed RP-HPLC method was used for quantitation of the three drugs in chloroquine dosage form samples. The method shows a great tendency in the classification between the genuine chloroquine and the adulterated ones in pharmaceutical preparations and breast milk.

Słowa kluczowe

breast milk chloroquine phosphate counterfeit desirability function fluorescence detection quality by design

Wydawca

University of Silesia in Katowice
Akademiai Kiado

Czasopismo

Acta Chromatographica

Rocznik

2021

Tom

Vol. 33, no. 3

Strony

234--244

Opis fizyczny

Bibliogr. 38 poz., rys., tab.

Twórcy

autor

Hassan Said A.

said.hassan@pharma.cu.edu.eg

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt

https://orcid.org/0000-0002-4766-0255

autor

Ibrahim Noha

Analytical Chemistry Department, Faculty of Pharmacy, Misr International University, Cairo, Egypt

autor

Elzanfaly Eman S.

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt

autor

El Gendy Ahmed E.

Analytical Chemistry Department, Faculty of Pharmacy, Misr International University, Cairo, Egypt

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Bibliografia

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