Vol. 9, Issue 7 (2020)

Author(s):
Jitesha Patel, Parth Patel and Rajashree Mashru

Abstract:
Reversed phase High-performance liquid chromatographic (RP-HPLC) and UV spectrophotometric methods were developed and validated for quantitative determination of Ranolazine and Metformin HCl. Different analytical validation parameter such as linearity, precision, accuracy, limit of detection, limit of quantification were determined according to ICH Q2[R1] guidelines. Separation was achieved by using Analytical Technologies Limited C18 (250 mm x 4.6 mm, 5µm) as stationary phase. The retention time for Ranolazine and Metformin HCl was 6.0±0.10 min and 3.4±0.15 min respectively. The UV Spectrophotometric method is based on first order derivative spectroscopy. Metformin HCl determined at 251nm (Zero crossing point of Ranolazine) and Ranolazine determined at 237nm (Zero crossing point of Metformin HCl) using methanol as a diluent. This method was validated as per ICH guideline. The Linearity of the calibration curve for each analyte in the desired concentration range was good (r²>0.989) by both the RP-HPLC and UV methods. The method showed good reproducibility and recovery with % RSD less than 2%.The proposed methods are highly sensitive, precise and accurate and hence successfully applied for the estimating assay of synthetic mixture.