Talks
Presentation Type
Oral Presentation
Discipline Track
Biomedical Science
Abstract Type
Research/Clinical
Abstract
Combined drug dosage forms are highly used since they can target more than one disease. For Ofloxacin and Racecadotril in bulk and combined dosage form a simple ,accurate and precise stability indicating simultaneous method was developed and validated by RP-HPLC (in isocratic system ) as per ICH Q2 R1 and FDA guidelines. This method was carried out by waters X bridge stainless steel C18 Column (250mm X4.6mm,5 micro meter) packed with ODS as stationary phase and methanol : acetonitrile :water (40:40:20 ) as mobile phase. As the pKa of both OFL and RAC are strong acidic mobile phase pH should be maintained below 6.0 so the pH of the mobile phase was adjusted to 2.7 by orthophosphoric acid. As the system was flow sensitive the flow rate was set at 0.8 mlmin-1 at room temperature and UV visible spectrometer was used as detector (at 210nm). As the validation carried out the method showed good linearity and correlation coefficient of ofloxacin and racecadotril , with good mean recovery value. For the determination of both the drugs in bulk and pharmaceutical formulations this validated method could be used perfectly. Further to ensure the specificity and stability the stress studies were performed.
Academic/Professional Position
Graduate Student
Recommended Citation
Das, Debashree Debasish and Chawla, Pooja, "Validated RP-HPLC Method For Simultaneous Estimation of Ofloxacin and Racecadotril in Bulk and Combined Pharmaceutical Formulations" (2023). Research Symposium. 7.
https://scholarworks.utrgv.edu/somrs/2022/talks/7
Included in
Validated RP-HPLC Method For Simultaneous Estimation of Ofloxacin and Racecadotril in Bulk and Combined Pharmaceutical Formulations
Combined drug dosage forms are highly used since they can target more than one disease. For Ofloxacin and Racecadotril in bulk and combined dosage form a simple ,accurate and precise stability indicating simultaneous method was developed and validated by RP-HPLC (in isocratic system ) as per ICH Q2 R1 and FDA guidelines. This method was carried out by waters X bridge stainless steel C18 Column (250mm X4.6mm,5 micro meter) packed with ODS as stationary phase and methanol : acetonitrile :water (40:40:20 ) as mobile phase. As the pKa of both OFL and RAC are strong acidic mobile phase pH should be maintained below 6.0 so the pH of the mobile phase was adjusted to 2.7 by orthophosphoric acid. As the system was flow sensitive the flow rate was set at 0.8 mlmin-1 at room temperature and UV visible spectrometer was used as detector (at 210nm). As the validation carried out the method showed good linearity and correlation coefficient of ofloxacin and racecadotril , with good mean recovery value. For the determination of both the drugs in bulk and pharmaceutical formulations this validated method could be used perfectly. Further to ensure the specificity and stability the stress studies were performed.