Abstract
A simple, specific and cost effective RP-HPLC method was developed for simultaneous estimation of Dosulepin and Methylcobalamin in bulk. In addition the developed method was applied to the suitable combined tablet dosage form ie., Prothiaden. As there is no UV or HPLC method for the simultaneous estimation of Dosulepin and Methylcobalamin, a need was felt to develop the method for the analysis of both drugs simultaneously. Chromatography was carried on Zorbax C8 column (150x4.5, 5) with mobile phase comprising of Ortho Phosphoric Acid buffer and Methanol in the ratio of 50:50 v/v. The flow rate was adjusted to 0.8 ml/min with PDA detection at 219.8 nm. The retention times of Dosulepin and Methylcobalamin were found to be 3.8 min, 1.9 min respectively and other replicate standard system suitability parameters are within the limit and uniform. The different analytical parameters such as accuracy, precision, linearity, robustness, limit of detection (LOD), limit of quantification (LOQ) were determined according to the International Conference on Harmonization (ICH) Q2B guidelines. The detector response was linear in the range of 0.9-2.7 mg/ml., 0.018- 0.054 mg/ml for Dosulepin and Methylcobalamin respectively. The proposed method was successfully applied for the reliable quantification of active pharmaceuticals present in the commercial formulations.
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