Analytical method validation on simultaneous estimation of Ozenoxacin and Benzoic acid in pharmaceutical formulation

• Autorzy: Ramireddy Amarnath Reddy , Behara Dilip Kumar

Identyfikatory

DOI

10.1556/1326.2022.01064

• Języki publikacji: EN

Abstrakty

EN

In this study, an accurate, simple, economical and precise Reversed-Phase High Pressure Liquid Chromatography (RP-HPLC) method was developed for the simultaneous estimation of Ozenoxacin and Benzoic Acid in a pharmaceutical cream formulation, according to the International Conference on Harmonisation (ICH) guidelines. Chromatographic separation was achieved by gradient elution, on RP-HPLC Instrument, equipped with column C8 (150 mm × 4.6 mm, 5 μm particle size) using Ultra Violet (UV) detector at 235 nm wavelength, by using Mobile Phase A: triethylamine, trifloroacetic acid and water (1:1:1000) and Mobile Phase B: methanol and Diluent: water, acetonitrile and triethylamine (500:500:1), at flow rate 0.8 mL min⁻¹; injection volume of 20 μL; column oven temperature 45 °C and sample temperature: 25 °C; Run time: 15 min. All the validation parameters were within the acceptance criteria, as per ICH requirements, for Ozenoxacin and Benzoic acid. Consequently, this method has found to be validated, simple, rapid and successfully applicable, to the simultaneous estimation of Ozenoxacin and Benzoic acid by RP-HPLC, for routine analytical testing in quality control, with a run time of 15 min and for future research studies. Forced degradation of Ozenoxacin cream 1% w/w formulation was performed and found that validated method has stability indicating potential that needs to be further studied.

Słowa kluczowe

EN

Ozenoxacin; Benzoic acid; impetigo; RP-HPLC; stability indicating

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2023
• Tom: Vol. 35, no. 3
• Strony: 278--285
• Opis fizyczny: Bibliogr. 27 poz., rys., tab., wykr.

Twórcy

autor

Ramireddy Amarnath Reddy

• Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University Anantapur (JNTUA), Ananthapuramu, Andhra Pradesh, 515002, India

• https://orcid.org/0000-0003-0330-6702

autor

Behara Dilip Kumar

• Chemical Engineering, JNTUA College of Engineering (Autonomous), Jawaharlal Nehru Technological University Anantapur (JNTUA), Ananthapuramu, Andhra Pradesh, 515002, India

• https://orcid.org/0000-0002-4005-7234

Bibliografia

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