Author(s):
Mohammad Aman Hakimoddin, Aejaz Ahmed, Khan Javed, Manyar Abuzaid Muzaffar
Email(s):
anamshaikh2805@gmail.com
DOI:
10.52711/0974-4150.2026.00060 
Address:
Mohammad Aman Hakimoddin*, Aejaz Ahmed, Khan Javed, Manyar Abuzaid Muzaffar
Department of Pharmaceutical Chemistry, JIIU’S Ali-Allana College of Pharmacy Akkalkuwa, Dist: Nandurbar
*Corresponding Author
Published In:
Volume - 19,
Issue - 5,
Year - 2026
ABSTRACT:
For the quantitative measurement of tadalafil in both bulk medication and oral jelly formulations, a reliable and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was created and approved. Using a C18 column (250 mm × 4.6 mm, 5 µm) and a mobile phase made of methanol and water (60:40 v/v) that had been adjusted to pH 3.5 with orthophosphoric acid, chromatographic separation was performed at a flow rate of 1.0 mL/min. A UV detector was used for detection at 286 nm. The linearity, accuracy, precision, specificity, limit of detection (LOD), limit of quantitation (LOQ), robustness, and ruggedness of the method were all validated in accordance with ICH Q2(R1) recommendations. Between 5 and 25 µg/mL, the linear response was seen, and the correlation value was 0.999. Recovery trials showed accuracy (99.2–101.5%), and precision percentage RSD values were typically less than 2%. Tadalafil content in oral jelly formulations was successfully assessed using this approach, which showed outstanding resistance to slight variations in chromatographic parameters. For routine tadalafil analysis and quality control, this established method is ideal.
Cite this article:
Mohammad Aman Hakimoddin, Aejaz Ahmed, Khan Javed, Manyar Abuzaid Muzaffar. Analytical Method Development and Validation RP-HPLC method for Estimation of Tadalafil in Bulk and Oral Jelly Formulation. Asian Journal of Research in Chemistry. 2026; 19(5):405-1. doi: 10.52711/0974-4150.2026.00060
Cite(Electronic):
Mohammad Aman Hakimoddin, Aejaz Ahmed, Khan Javed, Manyar Abuzaid Muzaffar. Analytical Method Development and Validation RP-HPLC method for Estimation of Tadalafil in Bulk and Oral Jelly Formulation. Asian Journal of Research in Chemistry. 2026; 19(5):405-1. doi: 10.52711/0974-4150.2026.00060 Available on: https://www.ajrconline.org/AbstractView.aspx?PID=2026-19-5-1
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