Stability indicating simultaneous validation of hydrochlorothiazide, dihydralazine, and propranolol with thestudy of forced degradation behavior through RP-HPLC in thepharmaceutical dosage form
Journal Title: Asian Pacific Journal of Health Sciences - Year 2017, Vol 4, Issue 3
Abstract
For the instantaneous assay of Hydrochlorothiazide, Dihydralazine and Propranolol in tablet, an easy, accurate and truthful RP-HPLC method have been developed as well as validated. Isocratic RP-HPLC method was developed on BDS hypersil C18, (250mm×4.6mm internal diameter, 5µ particle size) using mobile phase as 0.05M Potassium Dihydrogenortho Phosphate (pH-6.0): Acetonitrile (40:60v/v) at a 1.0 mL/min flow rate than at 215 nm detection was carried out using tunable absorbance detector (Waters 486). Study of forced degradation study was carried out through acid degradation, base degradation, thermal degradation, oxidation of the drug. The validation of method was carried out to observe accuracy, precision, linearity, in addition to robustness. The method was found to be linear in the concentration range of 10-30𝜇g/mL with correlation coefficient of 0.9996 for Hydrochlorothiazide,12.5-37.5𝜇g/mL with correlation coefficient of 0.9986 for Dihydralazine, and 20-60𝜇g/mLwith correlation coefficient of 0.9997 for Propranolol. Stress studies produce degradation products which did not hinder with the detection of Hydrochlorothiazide, Dihydralazine and Propranolol; therefore, the assay can be stability indicating.
Authors and Affiliations
Akhilesh Sharma
Keywords
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- EP ID EP525600
- DOI 10.21276/apjhs.2017.4.3.44
- Views 180
- Downloads 0
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