RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ACCURATE ESTIMATION OF ANTIHYPERTENSIVE IN PHARMACEUTICAL DOSAGE FORM

Manisha Subhash Kathole*, Dr. B. N. Thakare, Dr. K. R. Biyani

ABSTRACT

Azelnidipine is a new dihydropyridine derivative with calcium antagonistic activity. It is a first-pass hepatic metabolism drug, primarily metabolized by hepatic cytochrome P450 (CYP) 3A4, and has no active metabolite product. Azelnidipine is lipophilic and has a potent affinity for vascular smooth muscle cell membranes. It is a drug that has undergone preclinical and clinical studies and was launched as CALBLOCK® in Japan in 2003. The study aims to develop and validate the RP-HPLC method for estimating Azelnidipine in Pharmaceutical Dosage Form, focusing on the application of suitable analytical techniques, optimization, and validation in accordance with ICH guidelines. The study will also focus on selecting the appropriate drug and developing an analytical methodology. In this study, we found that the pharmaceutical dose tablet formulations containing Azelnidipine (AZP) may be accurately measured using the RP-HPLC method. The RP-HPLC technique is sensitive, accurate, precise, and repeatable; it also demonstrates high repeatability. Azelnidipine (AZP) tablet dosage formulation analysis may also be conducted with success. These techniques do not experience any influence from additives, matrices, etc. To further understand these trials, additional research on other medication formulations is needed.

Keywords: Azelnidipine; RP-HPLC; CALBLOCK; Pharmaceutical Dosage Form.