ISSN: 2249–9504
CAS CODEN: IJPCDX

VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS DETERMINATION OF COMMON COUGH AND COLD INGREDIENTS IN MULTICOMPONENT ORAL DRUG PRODUCTS

Abstract

Author(s): Sakshi Sawant*, Nitin Borkar

This research was done to develop a potential, reliable fast and efficient analytical method for various dosage forms (eg. Syrup, tablet, suspension etc) which could estimate all the major components of a cough and cold multicomponent formulation and also this method was validated. All common used components like pheniramine maleate, phenylephrine hydrochloride, acetaminohen, dextromethorphan hydrobromide, guafenesin, chlorpheniramine maleate, diphenhydramine in cough and cold category of products also covering more than one dosage forms ( eg. Syrups, suspensions, tablet etc) was used thus making the methodology by and large universal for the entire range of cough and cold products. This would help in using almost a common method of analysis for separation of most of the components instead of using a lot of separate methods for the same product or using a common method of analysis for a range of different dosage form of cough and cold category for a common set of components. This would save time and cost and ensure optimum usage of resources. Mobile phase of 0.01M 1-octane sulphonic acid sodium salt monohydrate (pH adjusted to 2.80 with 0rthophosphoric acid): Acetonitrile in a gradient ratio was used with a flow rate of 1.0 ml/min on a C18, 25 X 4.6 mm id, 5µ column at a wavelength of 264nm. This method was validated for parameters as accuracy, repeatability, reproducibility, robustness, linearity, limit of detection and limit of quantification. This HPLC method was found to be specific, linear, precise ,accurate, reproducible and robust and can be easily used for determination of common cough and cold analytes in a formulation as the results were found to be well within the acceptance range.

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