Development And Validation Of A Stability Indicating Rp-Hplc Method For The Determination Of Prucalopride Succinate In Bulk And Tablet

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dc.contributor.authorKanthale, S. B.en_US
dc.contributor.authorThonte, S. S.en_US
dc.contributor.authorPekamwar, S. S.en_US
dc.contributor.authorMahapatra, D. K.en_US
dc.date.accessioned2020-10-16T07:51:12Z
dc.date.available2020-10-16T07:51:12Z
dc.date.issued2020-03
dc.description.abstractA very simple, precise, economical, accurate, robust, and reproducible reverse phase-high-performance liquid chromatography method along with stability indicating attributes has been developed for estimating of prucalopride succinate (PRU) in both bulk and tablet formulation (PRUVICT 2). The estimation of the solutes was performed on a Grace C18 column of dimension 150 mm × 4.6 mm, 5 μm. PRU was eluted with acetonitrile: 0.02 M potassium dihydrogen phosphate in the ratio of 20:80 v/v in a 10 min isocratic mode at a flow rate of 1 ml/min at 30°C column temperature and monitored at a wavelength of 277 nm. The retention time of PRU was found to be 5.416 minutes. The Q2b validation of the analytical method revealed good linearity over the concentration range 2–12 μg/mL for IVA with r2 of 0.999. The mean recovery % over the three tested ranges of 50%, 100%, and 150% were found to be 100.173%, 99.077%, and 98.575%, respectively. In intra-day variability study, the % RSDs was detected to be 0.754, 1.032, and 0.482 whereas the inter-day variability study demonstrated % RSDs of 0.797, 0.559, and 0.524, respectively. The acid, alkali, boiled water, hydrogen peroxide, dry heat, and UV radiations based stress studies presented the formation of a variety of characteristic degradation products. The developed analytical method may be employed for the routine analysis of PRU in bulk and tablet formulations.en_US
dc.identifier.affiliationsSchool of Pharmacy, Swami Ramanand Teertha Marathwada University, Nanded-431606, Maharashtra, Indiaen_US
dc.identifier.affiliationsChannabasweshwar Pharmacy College, Latur-431512, Maharashtra, Indiaen_US
dc.identifier.affiliationsSchool of Pharmacy, Swami Ramanand Teertha Marathwada University, Nanded-431606, Maharashtra, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutical Chemistry, Dadasaheb Balpande College of Pharmacy, Nagpur-440037, Maharashtra, Indiaen_US
dc.identifier.citationKanthale S. B., Thonte S. S., Pekamwar S. S., Mahapatra D. K.. Development And Validation Of A Stability Indicating Rp-Hplc Method For The Determination Of Prucalopride Succinate In Bulk And Tablet. International Journal of Pharmaceutical Sciences and Drug Research. 2020 Mar; 12(2): 166-174en_US
dc.identifier.issn0975-248X
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/206304
dc.languageenen_US
dc.publisherMRI Publication Pvt. Ltd.en_US
dc.relation.issuenumber2en_US
dc.relation.volume12en_US
dc.source.urihttps://doi.org/10.25004/IJPSDR.2020.120211en_US
dc.subjectPrucalopride succinateen_US
dc.subjectValidationen_US
dc.subjectStabilityen_US
dc.subjectForced Degradationen_US
dc.subjectRP-HPLCen_US
dc.subjectTableten_US
dc.titleDevelopment And Validation Of A Stability Indicating Rp-Hplc Method For The Determination Of Prucalopride Succinate In Bulk And Tableten_US
dc.typeJournal Articleen_US
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