Method development challenges and regulatory expectation in nifedipine. (January 2017)

• Record Type: Journal Article
• Authors: Goswami, Dipanjan; Gurule, Sanjay J; Singh, Pravesh; Goru, NVS Satyanarayana; Modhave, Yogesh; Khuroo, Arshad H; Monif, Tausif
• Is Part Of: International journal of pharmacokinetics. Volume 2:Number 1(2017)
• Page Start: 21
• Page End: 37
• Publication Date: 2017-01
• Subjects: bioanalytical method validation -- interfering-compound separation -- pharmacokinetics -- photo-labile nifedipine; Pharmacokinetics -- Periodicals; 615.705
• DOI: 10.4155/ipk-2016-0004
• Languages: English
• ISSNs: 2053-0846

Abstract

Aim: A novel and accurate high-throughput tandem mass spectroscopic method has been developed and validated for determination of nifedipine, a calcium-channel blocker.Materials & methods: Nifedipine was detected on a triple quadruple tandem mass spectrometer by multiple reactions monitoring mode via ESI source.Results: The selective and sensitive method was linear in the concentration range of 0.501 to 360.100 ng/ml and reported no matrix effect. The percent accuracy of the method was found to be between 99.7 and 102.80%, while percentage of RSD was in range of 1.77 to 4.73%.Conclusion: Validated method was used for bioavailability studies under fasting and fed conditions.