Rambabu Chintala

The present study was undertaken to develop a validated stability-indicating liquid chromatography method for estimating Everolimus in commercial tablet dosage forms. Chromatographic separation was achieved on Kromasil C18column(100mm x 4.6 mm, 5m) with mobile phase containing potassium dihydrogen orthophosphate buffer and acetonitrile taken in the ratio 75:25 v/v. The pH was adjusted to 3.0 with dilute orthophosphoric acid at a flow rate of 1.0 mL/min and the eluent was monitored at 270 nm. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, precision, linearity, accuracy and robustness. Linearity range was found to be between 5-30 ppm and the linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating that the accuracy and precision of the method are good. Statistical analysis proved that the method was precise, reproducible, selective, specific, and accurate for analysis of Everolimus. All the degradation products formed during forced degradation studies were well separated from the analyte  peak.

A simple, selective, rapid, precise and economical reverse phase HPLC method has been developed for the determination of Metoprolol Succinate in dosage formulation. The analyte was resolved by using a mobile phase (Acetonitrile, water and 1 % ortho phosphoric acid in the ratio 70:27:3 v/v/v) at a flow rate 2.0 ml/min on an isocratic HPLC system (Agilent 1100 series with Chemstation software) consisting UV lamp detector, Aligent C-8, RP column (4.6 mm i.d x250 mm) at a wavelength of 280 nm.  The linear dynamic range for Metoprolol Succinate was 10 g/mL–200µg/mL. The limit of detection [LOD]and Limit of quantification[LOQ] for Metoprolol Succinate  was 0.0284µg/mL  and 0.094µg/mL respectively. 

A simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Dosulepin tablet dosage form. Isocratic elution at a flow rate of 1mL/min was employed on a symmetry Chromosil C18 (250x4.6mm, 5µm in particle size) at ambient temperature. The mobile phase consisted Methanol: Acetonitrile: 0.01M Phosphate buffer in the ratio of 55:20:25 (v/v/v). The UV detection wavelength was 230nm and 20 μL sample was injected. The retention time for Dosulepin was 3.46min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Dosulepin tablet dosage form and bulk drug.