The development and validation of a stability indicating RP-UPLC method for the simultaneous estimation of clarithromycin, amoxicillin, and vonoprazan in a physical mixture

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dc.contributor.authorSalva, Cen_US
dc.contributor.authorGalla, Ren_US
dc.date.accessioned2024-11-30T11:20:13Z
dc.date.available2024-11-30T11:20:13Z
dc.date.issued2024-05
dc.description.abstractA novel technique was developed for simultaneous quantification of clarithromycin (CLA) amoxicillin (AMO), and vonoprazan (VON) in a mixture using the reverse phase ultra-performance liquid chromatography (RP-UPLC) technique and validated as per International Council for Harmonization (ICH) guidelines as there was no literature published for its estimation by UPLC. The method was developed using an acquity UPLC system from waters corporation with Hibar Bis phosphonate C18 column (100 × 2.1 mm, 2 µm) at 35° C and tunable ultra-violet detector (TUV) with detection wavelength at 210 nm, has a run time of below 3 minutes. The mobile phase proportion of 60:40 of 0.1 N monobasic potassium phosphate buffer (pH 3.8) and acetonitrile at a flow velocity of 0.2 ml/ minute was utilized. Linearity was observed for CLA, AMO, and VON between the concentration ranges of 25–150, 25–150, and 1–6 µg/ml, respectively, and R2 was 0.999 for CLA, AMO, and VON. Accuracy and precision were within 2% of the coefficient of variation (RSD) for all drugs. The observed mean percentage recoveries for the CLA, AMO, and VON were determined to be 99.74%, 99.07%, and 99.8%, respectively. The stability of the approach was assessed using degradation studies by exposing it to acid, alkali, oxidizing agent, heat, Ultra Violet (UV) light, and water as per ICH guidelines.en_US
dc.identifier.affiliationsSeven Hills College of Pharmacy, Tirupati, Indiaen_US
dc.identifier.affiliationsInstitute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati, India.en_US
dc.identifier.citationSalva C, Galla R. The development and validation of a stability indicating RP-UPLC method for the simultaneous estimation of clarithromycin, amoxicillin, and vonoprazan in a physical mixture. Journal of Applied Pharmaceutical Science. 2024 May; 14(5): 193-202en_US
dc.identifier.issn2231-3354
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/237513
dc.languageenen_US
dc.publisherOpen Science Publishers LLPen_US
dc.relation.issuenumber5en_US
dc.relation.volume14en_US
dc.source.urihttps://doi.org/10.7324/JAPS.2024.165836en_US
dc.subjectNovelen_US
dc.subjectRP-UPLCen_US
dc.subjectmixtureen_US
dc.subjectvonoprazanen_US
dc.subjectquantificationen_US
dc.subjectstabilityen_US
dc.titleThe development and validation of a stability indicating RP-UPLC method for the simultaneous estimation of clarithromycin, amoxicillin, and vonoprazan in a physical mixtureen_US
dc.typeJournal Articleen_US
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