RESUMEN
A simple, Precise, Rapid reproducible and selective reverse phase HPLC method has been developed for the estimation of Sibutramine Hydrochloride monohydrate and its Impurity in Bulk as well as Formulation. The analyte was resolved by using Mobile phase [Sodium Dihydrogen phosphate and Acetonitrile] at the flow rate of 1.0 Ml/Min. on Isocratic HPLC system consisting of Jasco Make UV visible Detector of model UV 1575 and Jasco make HPLC pump of model PU 1580.An ODS C- 8 RP Column [4.6mm ID, 250mm L, particle size 5 Micron, at wavelength of 230 nm
Asunto(s)
Contaminación de Medicamentos , Cromatografía Líquida de Alta PresiónRESUMEN
Tamsulosin hydrochloride is used to treat the symptoms of an enlarged prostate, a condition technically known as benign prostatic hyperplasia or BPH. The analyte was resolved by using Mobile phase [Potassium Dihydrogen Orthophosphate and Acetonitrile] at the flow rate of 1.2 Ml/Min. on Isocratic HPLC system consisting of Jasco Make UV visible Detector of model UV 1575 and Jasco make HPLC pump of model PU 1580. An ODS C- 8 RP Column [4.6mm ID, 250mm L, particle size 5 Micron, at wavelength of 280 Nm. The linearity range was found to be 0.4 Ml/Ml for Tamsulosin and 0.12 mg/ml to 2.0 mg/ml for its Impurity. The proposed method is simple, accurate, rapid and selective. Percent Relative standard Deviation was found to be very low, below 2.0%, which indicates that method is highly precise and specific. Short Analysis time [= 10 min.] coupled with simplicity and ease of operation warrants use of the given method for analysis of Tamsulosin Hydrochloride along with its impurity as stated above in Bulk. Therefore, met hod can be useful in routine Quality Control Analysis in bulk drugs
Asunto(s)
Sulfonamidas , Cromatografía Líquida de Alta Presión/instrumentación , Sensibilidad y EspecificidadRESUMEN
Fixed dose combination tablets containing ambroxol HCI and cetirizine HCI are clinically used as mucolytic and antiallergic. Several spectrophotometric and HPLC methods have been reported for simultaneous estimation of these drugs with other drugs. The drugs individually and in mixture obeys Beer's law over conc. range 1.2-4.4 micro g/mL for cetirizine HCL and for ambroxol HCL 15-52 micro g/mL at all five sampling wavelengths [correlation coeff. Well above 0.995]. The mean recoveries from tablet by standard addition method were 100.18% [ +/- 2.4] and 100.66% [ +/- 2.31]. The present work reports simple, accurate and precise spectrophotometric methods for their simultaneous estimation from tablet dosage form