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Development and validation of stability indicating assay method for cinitapride in bulk & tablets

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dc.contributor.author Rehman, Atta-ur
dc.contributor.author Beg, Anwar Ejaz
dc.contributor.author Bushra, Rabia
dc.contributor.author Ashfaq, Maria
dc.contributor.author Zafar, Farya
dc.contributor.author Ali, Huma
dc.contributor.author Rizvi, Mehwish
dc.date.accessioned 2022-12-15T05:13:30Z
dc.date.available 2022-12-15T05:13:30Z
dc.date.issued 2017-11-03
dc.identifier.citation Beg, A. E., Bushra, R., Ashfaq, M., Zafar, F., Ali, H., & Rizvi, M. (2017). Development and validation of stability indicating assay method for cinitapride in bulk & tablets. Pakistan Journal of Pharmaceutical Sciences, 30. en_US
dc.identifier.issn 1011-601X
dc.identifier.uri http://142.54.178.187:9060/xmlui/handle/123456789/15124
dc.description.abstract A simple stability indicating UV-spectrophotometric method has been developed and validated for the determination of cinitapride hydrogen tartrate (CHT) in bulk and solid pharmaceutical dosage form. Drug absorption was measured in different analytical mediums however; maximum absorption was seen in 0.1 N HCl at wavelength (λmax) of 266 nm. The calibration curve was found to be linear over the concentration range from 6 to14µg/mL with the correlation coefficient value (r) of 0.999. The LOD and LOQ were estimated to be 0.1019µg/ml and 0.309µg/ml respectively. The accuracy was evaluated by determining the percent drug recovery, performed at three different levels of 50%, 100% and 150%. The% recovery was found to be in the range of 99.96–100.64%. The precision of the method was determined by inter-day and intra-day variations. The % RSD value <0.5 indicates the underlying method is precise and accurate as well. The developed method was applied to characterize in vitro assay content of few brands of cinitapride (1 mg) available in local market. No interference of the formulation excipients with the drug absorption was observed during assay. Drug substance and drug product were exposed to various stressed conditions (acid, base, oxidative, thermal and photolysis). Forced degradation testing of drug product showed that the oxidation (20%) was found to be the major degradation pathway of the cinitapride. However; drug estimation was not influenced in presence of degradation moieties formed during acid, base, oxidation, thermal and photolytic breakdown. Overall, the investigated technique is robust and specific that would be successfully used to quantify the cinitapride hydrogen tartarate in pharmaceutical dosage and bulk form in future. en_US
dc.language.iso en en_US
dc.publisher Karachi: Faculty of Pharmacy & Pharmaceutical Sciences University of Karachi en_US
dc.subject Cinitapride hydrogen tartarate en_US
dc.subject assay en_US
dc.subject stability indicating method en_US
dc.subject UV-spectrophotometer en_US
dc.subject tablet assay en_US
dc.title Development and validation of stability indicating assay method for cinitapride in bulk & tablets en_US
dc.type Article en_US


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