Abstract

STABILITY-INDICATING METHOD FOR ASSAY AND IMPUTIRTY PROFILING FROM AMLODIPINE AND METOPROLOL IN THEIR PHARMACEUTICAL DOSAGE FORMS USING RP-HPLC WITH UV/PDA DETECTOR

Jayesh Pandharinath Tamhanekar*, Sushama Raju Ambadekar, Vijay Arjun Bagul, Anand Radheshyam Tiwari

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Abstract

An objective of this research is to develop a stability-indicating method for the simultaneous determination of assay and impurities profiling from amlodipine and metoprolol in their pharmaceutical dosage form using reverse phase high-performance liquid chromatography (RPHPLC) with ultraviolet-photodiode array detector. The chromatographic separation of amlodipine, metoprolol, and their impurity peaks was achieved using an YMC-Triart PFP C18 column (250 × 4.6 mm, 5 μm particle size). A mobile phase composed of buffer solution 2 and acetonitrile (60: 40 v/v) was selected, and a flow rate of 1.2 mL/minute was monitored with an injection volume of 5 μL. The column oven and autosampler temperatures were maintained at 25, and detection was performed at 235 nm. The method was validated according to the International Council on Harmonization guidelines. The method was linear and accurate as correlation coefficient and % recovery were within the acceptance criteria. System suitability criteria were also fulfilled. This method is specifically developed as a stability-indicating method to rapidly and simultaneously estimate amlodipine, metoprolol, and their impurities. All the impurities and drug substances eluted before 25 min. Hence, the run time was set as 30 and 40 min for the assay and related substance test, respectively. Because all the impurities of amlodipine eluted within 25 min, the developed RP-HPLC method is simple, fast, and economical. The projected method can be utilized for routine analysis in the quality control department of the pharmaceutical industry.

Keywords: Amlodipine, Metoprolol, Stability-indicating method, Reverse phase high-performance liquid chromatography, Assay, Related Substances.