Simultaneous Estimation and Validation of Lc-MS Method for the Determination of Barnidipine in Human Plasma: Its Stability Indicating

Abstract

Various LC-MS/MS and RP-HPLC methods are reported in the literature for the estimation of barnidipine individually. According to the literature survey, there is no regulatory method reported for the estimation of barnidipine by LC-MS/MS in human plasma either in literature and pharmacopeia. Hence, in this study a Novel LC/MS/MS method was optimized and validated for simultaneous estimation and validation of barnidipine in human plasma in accordance with the USFDA, EMEA and other relevant regulatory guidelines. Bamidipine is an anti-hypertensive drug belonging to the dihydropyridine (DHP) group of calcium antagonists. It is available in a modified-release formulation which has a gradual onset of action and is effective in a single daily oral dose of 10 to 20 mg. Bamidipine has selective action against cardiovascular calcium antagonist receptors and its anti-hypertensive action is related to the reduction of peripheral vascular resistance secondary to its vasodilatory action. The clinical anti-hypertensive efficacy of barnidipine is similar to that of other DHP calcium antagonists such as nitrendipine and amlodipine, and anti-hypertensives belonging to other drug classes such as atenolol and enalapril. Barnidipine has been found to be as efficacious and well tolerated as hydrochlorothiazide in the management of hypertension in elderly patients. Barnidipine is generally well tolerated. As with other DHP calcium antagonists, vasodilator adverse events such as a headache, flushing and peripheral oedema account for most of the adverse events reported with its use and are usually transient. Oedema is less frequent than with amlodipine and nitrendipine. Its use is not associated with reflex tachycardia. The validated regulatory bioanalytical method for estimation of barnidipine by LC-MS/MS in human plasma is useful for analysis of subject samples to support generic ANDA applications for different regulatory authorities for introducing new generic drugs in affordable rates for the patients. Also the validated regulatory method would be used as supporting literature for developing and validating better method in CROs and clinical research organizations to support new generic drugs.