Simultaneous Determination of Thiocolchicoside and Ketoprofen in Bulk and Pharmaceutical Formulations by Validated Stability Indicating RP-HPLC Method

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