Abstract
The simultaneous determination of betamethasone, dexchlorpheniramine maleate, and sodium benzoate in pharmaceutical syrup was done by using a simple validated HPLC method. The chromatographic separation of the three analytes was done in a C18 column maintained at 25°C, using a mixture of acetonitrile and 0.02 M phosphate buffer solution pH 2.70 (35 : 65, v : v) as mobile phase. The isocratic elution was chosen with total flow rate of mobile phase maintained at 1.0 mL per minute. The analytes were detected by a UV-Vis detector set at 254 nm. Injection volume was set at 50 μl. The method was fully validated in terms of specificity, linearity, precision, accuracy, and robustness according to requirements of current guidelines and was proven to be suitable for the intended application.
Highlights
Betamethasone is a synthetic glucocorticoid possessing antiinflammatory [1] and antiallergic properties [2]
Sodium benzoate can be used for both the abovementioned purposes: it can increase the solubility of active principle [7], and it can be used as antimicrobial preservative [8, 9] to inhibit the development of micro-organism
To assure the reliability of analytical results, any method intended for the assay of active principle(s) and other components, such as preservative(s), in pharmaceutical dosage forms must be able to satisfy suitable performance levels, such as those required by AOAC International for quantitative method [17] and must be able to provide obligated validation data to authorities according to guidelines on analytical method validation, such as those issued by ICH [18] or FDA [19]
Summary
Betamethasone is a synthetic glucocorticoid possessing antiinflammatory [1] and antiallergic properties [2]. Journal of Analytical Methods in Chemistry determination of betamethasone, dexchlorpheniramine maleate, and sodium benzoate in pharmaceutical dosage forms. To assure the reliability of analytical results, any method intended for the assay of active principle(s) and other components, such as preservative(s), in pharmaceutical dosage forms must be able to satisfy suitable performance levels, such as those required by AOAC International for quantitative method [17] and must be able to provide obligated validation data to authorities according to guidelines on analytical method validation, such as those issued by ICH [18] or FDA [19]. An HPLC method using C18 column was developed and validated for simultaneous assay of betamethasone, dexchlorpheniramine maleate, and sodium benzoate in syrup
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