DEVELOPMENT AND VALIDATION OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TADALAFIL AND DAPOXETINE

DEVELOPMENT AND VALIDATION OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TADALAFIL AND DAPOXETINE

Registration ID: IJNRD_181334

Published ID: IJNRD2205059

DOI: Click Here to Get

Neha tarinnum , N.Harshitha , Om Sai N , P.Sridevi , Vinutha kommineni, M.Bhagavan Raju

Tadalafil and Dapoxitine, RP-HPLC Method, Simultaneous estimation, Validation, Forced degradation studies.

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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"DEVELOPMENT AND VALIDATION OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TADALAFIL AND DAPOXETINE", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.7, Issue 5, page no.553-561, May-2022, Available :https://ijnrd.org/papers/IJNRD2205059.pdf

Volume 7 Issue 5, May-2022

Pages : 553-561

Paper Reg. ID: IJNRD_181334

Published Paper Id: IJNRD2205059

Downloads: 000121161

Research Area: Engineering

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Published Paper PDF: https://ijnrd.org/papers/IJNRD2205059.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2205059

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

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