Method development challenges and regulatory expectation in nifedipine

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.