Abstract
Introduction: No methods were reported for the simultaneous determination of HCZ and CAN in the presence of CHL and DSA; accordingly, the aim of the presented research work is to provide highly selective, accurate and simple HPTLC method for the determination of the proposed mixture in pure forms and dosage form.
Method: TLC scanner 3 densitometer (Camag, Muttenz, Switzerland) was used for separation of HCZ, CAN, CHL and DSA mixtures and for quantification of HCZ and CAN on HPTLC silica gel 60 F-254 using ethyl acetate: methanol: glacial acetic acid (95: 5: 0.05 by volume), followed by densitometric measurement of bands at 270 nm.
Result: HPTLC method was successfully applied for separation of HCZ, CAN, CHL and DSA mixtures and for quantification of HCZ and CAN. Good resolution is indicated by the difference in the retention factor (R-f) values of (HCZ = 0.73, CAN = 0.36, CHL = 0.53, DSA = 0.86). The proposed method was validated according to International Conference on Harmonization (ICH) guidelines.
Conclusion: The proposed HPTLC method provides sensitive, accurate, and selective means for determination of mixtures of HCZ and CAN in the presence of impurities of HCZ; (CHL and DSA) using HPTLC method; which gives an advantage over previously reported methods for the analysis of HCZ and CAN mixtures that do not consider interference of impurities.
The proposed method could be applied for the determination of pure HCZ and CAN in the presence of (CHL and DSA) both in bulk powder and in pharmaceutical formulations.