Abstract
A HPLC-UV method, for determination of dextromethorphan hydrobromide in syrup, was validated. The chromatographic analysis was performed using an RP-18, Nucleodur chromatographic column (250 mm � 4 mm, 5 �m) at constant temperature (50oC) with a mobile phase consisting of a mixture of acetonitrile/methanol (70:30 v/v) with sodium docusate (as ion pair agent) and ammonium nitrate, pH = 3.4. The flow rate of the mobile phase was 1 mL/min and the detection was carried out at 280 nm. System suitability, specificity, linearity, precision, accuracy, limit of detection and limit of quantification agreed with current pharmacopeial requests. The method is suitable for routine analysis of dextromethorphan hydrobromide in syrup.
Highlights
Method validationNICOLAE AVRAM1, SIMONA CODRUTA HEGHES2, LUCA-LIVIU RUS3*, ANCA MARIA JUNCAN3, LUCIA MARIA RUS2, LORENA FILIP4, CORINA ROMAN FILIP5,6 1 S.C
This paper describes the development and validation of an HPLC-UV method for the determination of DXHB in syrup, considering latest validation guidelines and protocols [26,27,28,29,30,31,32,33]
Apparatus and chromatographic conditions Ultrapure water was prepared by means of a Simplicity apparatus (Millipore), weighing was performed on a Mettler Toledo analytical balance, density was determined by means of KEM digital densimeter, chromatographic analysis was performed on an Rigol L-3000, HPLC system
Summary
NICOLAE AVRAM1, SIMONA CODRUTA HEGHES2, LUCA-LIVIU RUS3*, ANCA MARIA JUNCAN3, LUCIA MARIA RUS2, LORENA FILIP4, CORINA ROMAN FILIP5,6 1 S.C. A HPLC-UV method, for determination of dextromethorphan hydrobromide in syrup, was validated. The method is suitable for routine analysis of dextromethorphan hydrobromide in syrup. Dextromethorphan hydrodromide (DXHB) has been used as antitussive for more than half a century [1], single or in combinations [2]. This paper describes the development and validation of an HPLC-UV method for the determination of DXHB in syrup, considering latest validation guidelines and protocols [26,27,28,29,30,31,32,33]
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