Paper Title
DEVELOPMENT AND VALIDATION OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TADALAFIL AND DAPOXETINE
Article Identifiers
Authors
Neha tarinnum , N.Harshitha , Om Sai N , P.Sridevi , Vinutha kommineni, M.Bhagavan Raju
Keywords
Tadalafil and Dapoxitine, RP-HPLC Method, Simultaneous estimation, Validation, Forced degradation studies.
Abstract
A new stability indicating RP HPLC method has been developed and validated for simultaneous estimation of Tadalafil and Dapoxitine in bulk and dosage forms. The method involves separation on Xterra C18 column (250mm x 4.6mm x5µm particle size). The optimized mobile phase consists of 0.1% OPA (pH 2.8) and Methanol (45:55v/v) with a flow rate of 1ml/min and UV detection at 229mn. Retention time was 2.78 min (Tadalafil), 3.71 min (Dapoxitine). Linearity range was 20-100 ug/ml (Tadalafil), 60-300 ug/ml (Dapoxitine). Accuracy was in the range of 96.92-100.35% for both drugs. Precision was 0.8% and 0.5% for Tadalafil and Dapoxitine. LOD and LOQ are 0.42ug/ml and 1.38 ug/ml for Tadalafil, 0.27ug/ml and 0.89ug/ml for Dapoxitine. The method developed is more sensitive, accurate and precise than the methods reported earlier. Retention time and run time were also less and hence the method is economical. When applied for tablet assay, drug content was within 98.55-101.4 % of labelled content. Forced degradation studies indicated the suitability of the method for stability studies.
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How To Cite (APA)
Neha tarinnum, N.Harshitha, Om Sai N, P.Sridevi, & Vinutha kommineni, M.Bhagavan Raju (May-2022). DEVELOPMENT AND VALIDATION OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TADALAFIL AND DAPOXETINE. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 7(5), 553-561. https://ijnrd.org/papers/IJNRD2205059.pdf
Issue
Volume 7 Issue 5, May-2022
Pages : 553-561
Other Publication Details
Paper Reg. ID: IJNRD_181334
Published Paper Id: IJNRD2205059
Downloads: 000121986
Research Area: Engineering
Country: -, -, -
Published Paper PDF: https://ijnrd.org/papers/IJNRD2205059.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2205059
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Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)
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