Document Type: Original Article

Authors

1 B.K. Mody Government Pharmacy College, New England Avenue, Piscataway, NJ, Near Aji Dam, Rajkot, Gujarat, India, Postal code: 360003

2 Amneal pharmaceutical LLC, Murray Road, Hanover, NJ 07936, USA

Abstract

This research study aimed at developing and validating a simple, precise, accurate, specific and economical spectrophotometric method for simultaneous estimation of Ranolazine (RANO) and Metformin hydrochloride (MET) in synthetic mixture. This method is based on first order derivative spectroscopy.Ranolazine and Metformin hydrochloride exhibited absorbance at working wavelength 232.86 nm (Zero crossing point of Metformin hydrochloride) and 249.29 nm (zero crossing point of Ranolazine) respectively using water as a diluent. This method was validated as per ICH guideline. Linearity was established over the concentration range of 2-35 μg/mL both of Ranolazine and Metformin hydrochloride with correlation coefficients 0.999 and 0.998, respectively. Accuracy was obtained between 98.48-101.85% and 98.25-100.88% for Ranolazine and Metformin hydrochloride respectively. LOD and LOQ were found to be 0.08 μg/mL and 0.25 μg/mL for Ranolazine and 0.25 μg/mL and 0.77 μg/mL for Metformin hydrochloride, respectively.The results revealed that, the developed method was suitable for the routine analysis of determination of Ranolazine and Metformin hydrochloride in combine dosage form.
Keywords: Ranolazine; Metformin hydrochloride; First order derivative; UV spectrophotometry; ICH guideline

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