International Journal of Pharma and Bio Sciences
ijpbs.net
editorijpbs@rediffmail.com (or) editorofijpbs@yahoo.com (or) prasmol@rediffmail.com
10.22376/ijpbs.2019.10.1.p1-12
Volume 4 Issue 1
2013 (January - March)
DEVELOPMENT OF STABILITY INDICATING METHOD FOR VALIDATION OF LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE DRUGS IN SOLID DOSAGE FORM BY RP-HPLC
The substance used in all such preparations must be in the purest form available. Pharmaceutical analysis is a vital part of the pharmaceutical chemistry. Analysis is an important task for all the research and development activities involving medicinal substances. It forms the basis of quality, which is the prime concern regarding medicines of human life. Thus pharmaceutical analytical chemistry may be defined as that branch of practical chemistry which deals with the resolution, separation, identification, determination, and purification of a given sample of a medicine or a pharmaceutical; the detection and estimation of impurities that may be present therein is also included. System Suitability Passes. Tailing factor is not more than 2.0%. The Correlation coefficient for Losartan potassium is 0.99937 and for Hydrochlorothiazide is 0.99967. The method is validated for Linearity from 70% to 130% of target concentration. Chromatograms of Different concentration were performed. RSD for Peak area and retention time of five replicate injections is found within the specified limit. System suitability passes and method is validated for system precision. The allowable variation in the flow rate of the mobile phase is ± 10%. The Percent change is assay value is less than 2.0% after 24 hours for the sample solution. Therefore the solution is stable for 24 hours at ambient temperature. This validation has been carried out as per ICH Q2 (R1) and the method has been validated as per approved protocol.
SHAIKH ANIS
Quantitated, Resolution, Theoretical plates, Antihypertensive, Chromatograms
621-638