The Thai Journal of Pharmaceutical Sciences
Abstract
Background: In the present study, a simple, sensitive, rapid, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method with diode array detection was developed and validated for simultaneous estimation of Metformin hydrochloride (MET) and Ranolazine (RANO) in a synthetic mixture. Material and Method: The method was developed using isocratic elution mode on a reversed-phase. Chromatographic separation was performed on ACE CN C18 (250 mm, 4.5 mm, 5 μm) column and a mobile phase consisting of methanol: acetonitrile:ammonium formate (45:45:10% v/v/v) with 10% formic acid to adjust the pH to 6.0, at a flow rate of 1.0 ml/min. Detection and quantification of all the analytes were carried out at 230 nm using a photodiode array detector. Result: The method was found to be linear in the range of 1–50 μg/ml for RANO and 2–100 μg/ml for MET. Percentage recovery was found in the range of 99.07–101.53% for RANO and 99.59–100.45% for MET. The RSD of precision and repeatability was found lower than 1% for each drug. Validation of the method was carried out as per International Council on Harmonization guideline Q2 (R1). Conclusion: The proposed RP-HPLC method can be highly suitable for the analysis of RANO and MET without interference.
DOI
10.56808/3027-7922.2572
First Page
287
Last Page
292
Recommended Citation
Patel, Ashok B.; Gol, Dhruvanshi A.; Makwana, Rahul L.; Vyas, Amitkumar J.; Patel, Ajay I.; Patel, Nilesh K.; Faldu, Shital D.; and Lumbhani, Arvind N.
(2022)
"Analytical method for simultaneous estimation of ranolazine and metformin hydrochloride by validated RP-HPLC-DAD method,"
The Thai Journal of Pharmaceutical Sciences: Vol. 46:
Iss.
3, Article 6.
DOI: https://doi.org/10.56808/3027-7922.2572
Available at:
https://digital.car.chula.ac.th/tjps/vol46/iss3/6