DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DOXYCYCLINE HYCLATE AND TINIDAZOLE IN BULK AND TABLET DOSAGE FORM

摘要

High Performance Liquid Chromatography (HPLC) methods are described for determination of drugs as a single or in combined formulations. The objective of the present study was to develop and validate novel, accurate, sensitive, precise, rapid and isocratic Reverse Phase HPLC (RP-HPLC) method for the simultaneous determination of Doxycycline hyclate (DOX) and Tinidazole (TIZ) in bulk and combined tablet dosage form. The separation was achieved on Zorbax C8 column (250mm × 4.6mm, 5μm) with mobile phase consisting of 20mM Potassium dihydrogen ortho phosphate (pH 6, adjusted with triethylamine):Acetonitrile (60:40 % v/v) at a flow rate of 1 ml/min. UV detection at 293nm. DOX and TIZ obeyed linearity in the concentration range of 10-50 μg/ml (r2= 0.9993) and 10-50 μg/ml (r2= 0.9987) respectively. The asymmetric factors were found to be 1.12 for DOX and 0.97 for TIZ. The developed method was validated as per ICH guidelines. It was concluded that the method can be used for routine analysis of DOX and TIZ in combined formulations