TY - JOUR
T1 - Stability Indicating Assay Method for Simultaneous Estimation of Tadalafil and Dapoxetine Hydrochloride by RP-HPLC in Bulk
AU - Khatal, Parnika Hareshwar
AU - D’souza, Kevita
AU - Syeda, Alisha
AU - Muddukrishna, B. S.
AU - Vasantharaju, S. G.
N1 - Funding Information:
The authors express their gratitude to Dr. Ashok Panwar AKUMS Drugs and Pharmaceuticals Ltd, Hardwar (UK) for providing the gift samples of API and Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal for granting the excess to the facilities to carry the research work.
Publisher Copyright:
© 2021, Colegio de Farmaceuticos de la Provincia de Buenos Aires. All rights reserved.
PY - 2021
Y1 - 2021
N2 - A new simple validated RP-HPLC stability indicating assay method was developed for simultaneous estimation of dapoxetine hydrochloride and tadalafil in bulk drug. C18 Phenomenex Hyper Clone™ BDS column (250 × 4.5 mm, 5 μm), was used along with mobile phase composition of acetonitrile: potassium phosphate buffer 10 mM (55:45 at pH 3.2 ± 0.1). Flow rate for study was 1 mL/min whereas response curve was measured with photodiode array detector at 298 nm. Tadalafil retention time was 3.9 min and that of dapoxetine hydrochloride was 4.9 min. Linearity of both drugs were found between the range of 6-16 μg/mL. The stability indicating ability of the method was establish by analysing drug sample by acid and alkaline hydrolysis, photolytic, oxidative and thermal conditions. The developed method is expeditious, precise and simple and can be implemented for quality control studies.
AB - A new simple validated RP-HPLC stability indicating assay method was developed for simultaneous estimation of dapoxetine hydrochloride and tadalafil in bulk drug. C18 Phenomenex Hyper Clone™ BDS column (250 × 4.5 mm, 5 μm), was used along with mobile phase composition of acetonitrile: potassium phosphate buffer 10 mM (55:45 at pH 3.2 ± 0.1). Flow rate for study was 1 mL/min whereas response curve was measured with photodiode array detector at 298 nm. Tadalafil retention time was 3.9 min and that of dapoxetine hydrochloride was 4.9 min. Linearity of both drugs were found between the range of 6-16 μg/mL. The stability indicating ability of the method was establish by analysing drug sample by acid and alkaline hydrolysis, photolytic, oxidative and thermal conditions. The developed method is expeditious, precise and simple and can be implemented for quality control studies.
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M3 - Article
AN - SCOPUS:85123410719
SN - 0326-2383
VL - 40
SP - 49
EP - 56
JO - Latin American Journal of Pharmacy
JF - Latin American Journal of Pharmacy
IS - 1
ER -