A Study On Method Development And Validation For The Estimation Of Anti T.B Drugs In Oral Dosage Form By Rp- Hplc1

Tue, 23 Apr 2024 00:00:00 +0000

The pharmaceutical analysis defined as “the branch of practical chemistry which deals with the resolution, separation, identification, determination and purification of a given sample of a medicine, the detection and estimation of impurities, which may be present in drug substance (or) given sample of medicine”. Chronological order of the events that are the most notable in the development of the present state of the field. Since the various types of chromatography (liquid, gas, paper, thin-layer, ion exchange, supercritical fluid, and electrophoresis) have many features in common, they must all be considered in development of the field. Analytical method development and method validation was performed for RP-HPLC method for the Isoniazid and Rifampicin in tablet formulation as per ICH norms for the following parameters: system suitability, linearity and precision (repeatability), intermediate precision (ruggedness), specificity and accuracy. From the results obtained, it was observed that the developed method was proven to be specific, precise, linear, accurate, rugged and robust and is suitable for its intended purpose.

RP-HPLC Method Development Validation And Degradation Studies For Combined Tablet Dosage-Form Of Saxagliptin & Dapaglifozin

Wed, 24 Apr 2024 00:00:00 +0000

A new simple, rapid, economical reverse phase high performance liquid chromatographic method was developed for the determination of Dapagliflozin and Saxagliptin in bulk and dosage-form. The separation was carried out by using column as Hypersil ODS-C18 (250mm×4.6 mm i.d.2.5µm), mobile phase Methanol: Acetonitrile: acetate buffer (pH of4.0)40:40:20 v/v, at a flow rate of 1.0ml/min, diluent as 80:20v/v mixture of water & methanol used. The detection was made by UV-Vis. Spectrophotometer at 228nm. The retention times were 2.314min for Dapagliflozin and 2.904min for Saxagliptin. Calibration curve was linear over the concentration range of 2.04 to 12.05μg/ml for Dapagliflozin and 1.06 to 6.10μg/ml for Saxagliptin, mean recoveries obtained for Dapagliflozin and saxagliptin were 99.89-100.37% and 100.37-100.83% respectively, limit of detection and limit of quantification were found to be 0.257 & 0.780µg/ml and 0.439 & 1.33µg/ml respectively. The propose method was validated as per the ICH guidelines parameters. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug in the combined dosage form.

IJPAR JOURNAL

A Study On Method Development And Validation For The Estimation Of Anti T.B Drugs In Oral Dosage Form By Rp- Hplc1

RP-HPLC Method Development Validation And Degradation Studies For Combined Tablet Dosage-Form Of Saxagliptin & Dapaglifozin