• Jayesh Pandharinath Tamhanekar
• Dr. Sushama Raju Ambadekar
• Vijay Arjun Bagul

An objective of this research is to develop a novel and common reverse phase liquid chromatographic method for the simultaneous determination of Assay and impurities in Amlodipine and Metoprolol from Pharmaceutical dosage form. The chromatographic separation of Amlodipine, Metoprolol and their impurity peaks was achieved using YMC-Triart PFP, C18 Column (250 mm x 4.6 mm, 5 µm particle size). Mobile phase composed of Buffer solution 2 and acetonitrile (60: 40 v/v) was selected and a flow rate of 1.2 ml/minute is monitored with injection volume of 5 µl. Column oven temperature and autosampler temperature was maintained at 25ºC. Detection was carried out at 235 nm. The method was validated as per International Council on Harmonization (ICH) guidelines. The method was found to be linear and accurate as correlation coefficient and % recovery was within the acceptance criteria. System suitability criteria were also fulfilled. This method is specifically developed for rapid and simultaneous estimation of Amlodipine, Metoprolol as well as their impurities. All the impurities and drug substances elute before 25 minutes hence run time was set as 30 minutes for Assay and 40 minutes for Related Substances test. As all the impurities of Amlodipine elute within 25 minutes, developed reverse phase high-performance liquid chromatography (RP-HPLC) method is simple, fast and economical. The projected method can be utilized for routine analysis in the quality control department from pharmaceutical industry.

Amlodipine, Metoprolol, RP-HPLC, Simultaneous estimation, Assay, Related Substances.

"DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS AND RAPID DETERMINATION OF ASSAY AND RELATED SUBSTANCES OF AMLODIPINE AND METOPROLOL IN PHARMACEUTICAL DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.8, Issue 10, page no.d163-d177, October-2021, Available :http://www.jetir.org/papers/JETIR2110319.pdf

"DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS AND RAPID DETERMINATION OF ASSAY AND RELATED SUBSTANCES OF AMLODIPINE AND METOPROLOL IN PHARMACEUTICAL DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.8, Issue 10, page no. ppd163-d177, October-2021, Available at : http://www.jetir.org/papers/JETIR2110319.pdf