Open AccessResponse Surface Method Aided Development and Validation of Stability Indicating RP-HPLC-UV Method for Impurities of Dextromethorphan Hydrobromide in API and Three Marketed Formulations
Author(s) -
Irshad Alam,
Aquil-ur-Rahim Siddiqui
Publication year - 2021
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2021.23361
Subject(s) - chemistry , chromatography , impurity , detection limit , high performance liquid chromatography , volumetric flow rate , resolution (logic) , box–behnken design , analytical chemistry (journal) , distilled water , linearity , response surface methodology , physics , organic chemistry , quantum mechanics , artificial intelligence , computer science
An innovative, specific, economical and precise method was developed and validated by employingreverse phase high performance liquid chromatography (HPLC) for contemporaneous estimation ofdextromethorphan hydrobromide (DHB) along with its impurities in liquid formulation with forceddegradation studies and confirmation of content of DHB in composition label in three marketformulations along with their impurities were detected by this method. The optimized chromatographicconditions comprised of column (25 cm × 0.46 cm) × 5 μm Kromasil C8 bearing flow rate of 1.5mL/min and wavelength 220 nm for UV-estimation. Design of experiments were implemented byfollowing Box Behnken design with most optimum parameters selected as follows, column temperature(A), flow rate (B) and pH (C) with corresponding responses comprised of resolution between relatedcompound A (RCA) and DHB (Y1), tailing of DHB (Y2) and resolution between related compound B(RCB) and DHB (Y3). Stress testing was performed and proved that method was stable as no interferingpeaks were observed. All validation parameters including suitability, linearity, accuracy, specificity,limit of detection, limit of quantitation, ruggedness, robustness and stress study were evaluated as perupdated ICH guidelines and found to be within limit for pure DHB and detected impurities.