Validation of a Novel and Sensitive RP-HPLC Method for Simultaneous Determination of Cefixime Trihydrate and Sodium Benzoate in Powder for Oral Suspension Dosage Form

Abstract

A novel, specific, precise, simple, and accurate RP-HPLC method is developed and validated for simultaneous determination of Cefixime trihydrate (CFX) and Sodium benzoate (SDM) in powder for oral suspension (POS) dosage form. RP-HPLC method is performed on the Agilent Eclipse XDB C8 column (250 mm X 4.6 mm, 5μm particle size, using buffer solution of pH 2.8 containing 0.02M sodium dihydrogen phosphate: Acetonitrile (50:50 v/v) as the mobile phase at a flow rate of 1.0 mL/min, injection volume 10 µL and UV detection at 229 nm. And the total run time was 7.0 min. Linear relationships are obtained in the ranges of 5-200 µg/mL and 2-40 µg/mL for CFX and SDM, respectively, with significantly different R t values of 2.203 and 3.970 min for CFX and SDM with correlation coefficients (r) >0.9999, limits of detection of 1.36 and 0.21 µgmL -1 and limits of quantitation was 4.14 and 0.64 µgmL -1 for CFX and SDM, respectively. The obtained results for the suggested method were statistically compared with those obtained by official or the reported method for CFX and SDM, respectively using student's-t and F-ratio tests, showing that the methods are accurate and precise. This method is validated according to ICH guidelines and USP requirements for new methods, which include accuracy, precision, specificity, LOD, LOQ, robustness, ruggedness, linearity and range. Hence this RP-HPLC method is suitable for quality control of raw materials and finished products. The accurate determination of low levels of both drugs is very important for the analysis of forensic problems.

Development and Validation of an HPLC Method for Simultaneous Assay of Potassium Guaiacolsulfonate and Sodium Benzoate in Pediatric Oral Powder

“…This reduces chest congestion by making coughs more productive. Sodium benzoate is a preservative widely used in oral pharmaceutical preparation [ 2 , 3 ] to inhibit the development of microorganism. Besides its antimicrobial property, sodium benzoate was also used to increase the solubility of active ingredients, like in the caffeine and sodium benzoate injection [ 4 ].…”

“…Potassium guaiacolsulfonate was determined in bulk active compounds by UV-Vis spectrometry [ 5 ] and by HPLC in an C18 column in both bulk active compounds [ 6 ] and in pharmaceutical dosage forms [ 7 , 8 ]. Sodium benzoate was analyzed by volumetric titration [ 4 ] and by HPLC in the C18 column [ 2 , 3 , 9 ] in bulk material and dosage forms. Up to now, only one method for simultaneous analysis of potassium guaiacolsulfonate and sodium benzoate has been published using HPLC in the C18 column [ 8 ], however, the paper did not provide any information about the validation and performance capacity of this method.…”

Simultaneous Assay of Dexchlorpheniramine Maleate, Betamethasone, and Sodium Benzoate in Syrup by a Reliable and Robust HPLC Method

“…Sodium benzoate can be used for both the abovementioned purposes: it can increase the solubility of active principle [7], and it can also be used as antimicrobial preservative [8, 9] to inhibit the development of micro-organism. So, the assay of sodium benzoate is required in these cases for quality control purpose.…”

“…The assay of sodium benzoate can be done by volumetric titration [7]. However, for the simultaneous assay of sodium benzoate and other analytes, HPLC in C18 column was the most common choice of analytical technique [8, 9, 16]. Up to now, no method has yet been published for simultaneous determination of betamethasone, dexchlorpheniramine maleate, and sodium benzoate in pharmaceutical dosage forms.…”

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“…Thus, a variety of methods have been developed for its determination including spectrophotometric [41,42], thin layer chromatography [43] and HPLC [44][45][46][47][48][49][50][51][52][53]. Recently, an HPLC method [54] has been published for simultaneous determination of both CFX and SDB together in pure or dosage forms. The combination of these two drugs is not official in any pharmacopoeia.…”