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

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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.

Document Type: Research Article

Affiliations: 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.

Publication date: September 1, 2008

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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