Anuradha V

A new RP – HPLC method was developed for the simultaneous determination of  Montelukast and Rupatadine fumerate in combined dosage form. An Inertsil C18 column(100 x 4.6, 5µm) was used with mobile phase of composition Methanol : Buffer(0.1% triethyl amine in water with pH adjusted to 3.0 (70:30v/v at pH 4.6) at a flow rate of 1.0 mL/min and injection volume of 20µL with UV detection at 266 nm for separating Montelukast and Rupatadine fumerate. The retention time of Rupatadine fumerate and Montelukast were 5.76 min and 2.86 min respectively. The runtime of the analysis was 6 minutes. The specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), ruggedness and robustness of the developed method were studied to validate as per ICH guidelines. The Linearity range for Montelukast and Rupatadine fumerate were 5.0 – 30.0 µg/ml and 5.0 – 30.0 µg/ml, respectively. The percentage recoveries were in the range for Montelukast and Rupatadine fumerate98.80-100.11 % and 99.06-99.44 %, respectively. The developed  method could be used for routine analysis of Montelukast and Rupatadine fumeratein their combined dosage forms.

A new validated RP – HPLC method was developed for the simultaneous determination of Thiocolchicoside and Ketoprofen in combined dosage form. The method developed produced high sensitivity, precision and accuracy. An isocratic C18 (Inertsil ODS, 250 x 4.6 mm, 5µ) column was used with mobile phase of composition Acetonitrile: Phosphate buffer (70: 30 at pH 4.6) at a flow rate of 1.0 mL/min with UV detection at 258.2 nm for separating Thiocolchicoside and Ketoprofen. The retention time of Thiocolchicoside and Ketoprofen were 2.4 min and 3.5 min respectively. The developed method was validated for specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness as per ICH guidelines. Linearity for Thiocolchicoside and Ketoprofen were found in the range of 2.0 – 12.0 µg/ml and 6.2-38.75 µg/ml, respectively. The percentage recoveries for Thiocolchicoside and Ketoprofen ranged from 99.35- 100.21% and 98.66-99.29 %, respectively. The proposed method could be used for routine analysis of Thiocolchicoside and Ketoprofen in their combined dosage forms. All the proposed methods for Thiocolchicoside and ketoprofenare simple, selective, reproducible and specific with good precision and accuracy. The method was proved to be superior to most of the reported methods. These proposed methods for estimation of selected drugs were successfully applied either in tablet dosage form. More over the low solvent consumption along with short retention time of 2.4 and 3.5 for both Thiocolchicoside and Ketoprofen to be cost effective when compared to other developed method shown in literature reviews. The proposed method can be used as alternative methods to the reported ones for the routine determination of selected drugs under the study in tablet dosage form