Simultaneous Determination of a Ternary Mixture of Doxylamine Succinate, Pyridoxine Hydrochloride, and Folic Acid by the Ratio SpectraZero-Crossing, Double DivisorRatio Spectra Derivative, and Column High-Performance Liquid Chromatographic Methods

Author:

Pathak Ashutosh1,Rajput Sadhana J1

Affiliation:

1. The Maharaja Sayajirao University of Baroda, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, Quality Assurance Laboratory, G.H. Patel Building, Donor's Plaza, Fatehgunj, Vadodara, Gujarat, India390 002

Abstract

Abstract Three simple, rapid, and accurate methods, i.e., the derivative ratio spectrazero-crossing method (method I), double divisorratio spectra derivative method (method II), and column reversed-phase high-performance liquid chromatographic (RP-HPLC) method (method III) were developed for the simultaneous determination of doxylamine succinate (DOX), pyridoxine hydrochloride (PYR), and folic acid (FA) in their ternary mixtures and in tablets. In methods I and II, the calibration graphs were linear in the range of 2.580, 1.040, and 1.030 g/mL for DOX, PYR, and FA, respectively. In the HPLC method, the separation of these compounds was performed using mobile phase consisting of 0.05 M phosphate buffer (pH 6.3)methanolacetonitrile (50 + 20 + 30, v/v/v), and UV detection was performed at 263 nm. Linearity was observed between the concentrations of the analytes and peak areas [correlation coefficient (r) 0.9998] in the concentration range of 1.0200, 4.0600, and 4.0600 g/mL for DOX, PYR, and FA, respectively. The standard deviation of retention time in method III was 0.011, 0.015, and 0.016 for DOX, PYR, and FA, respectively. The precision studies for all of the methods gave relative standard deviation values of <2. The results obtained from the methods were statistically compared by means of Student's t-test and the variance ratio F-test. It was concluded that all of the developed methods were equally accurate, sensitive, and precise. These methods could be applied to determine DOX, PYR, and FA in their combined dosage forms.

Publisher

Oxford University Press (OUP)

Subject

Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry

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