Journal of Developing Drugs
Open Access
ISSN: 2329-6631
+44 1478 350008
ISSN: 2329-6631
+44 1478 350008
Mohiuddin TM
Bangladesh
Research Article
Analytical Method Validation of Testosterone Undecanoate Soft Gelatin Capsule by RP-HPLC Method
Author(s): Md Didarul Islam, Mehedi Hasan M, Mohiuddin TM, Md Mynul Hassan, Asheful Latif and Papia HaqueMd Didarul Islam, Mehedi Hasan M, Mohiuddin TM, Md Mynul Hassan, Asheful Latif and Papia Haque
A rapid, sensitive, selective reversed phase HPLC method has been validated for the quantification of testosterone undecanoate from Andriol® soft gelatin capsule. During validation active pharmaceutical ingredient (API) has been separated by C18 (4.6 mm × 250 mm, 5 μm) column, 100% methanol as mobile phase, flow rate of 0.8 ml/min and detection wavelength at 240 nm. The method was validated according to USP and ICH guideline requirements which includes specificity, accuracy, precision, linearity and range and robustness. Linearity of standard spiked sample was observed for each working day and coefficient of determination (r2) has been found >0.99 each day in concentration ranging from 20-60 ppm. Recovery was found from 98.87-100.02% for 20, 40 and 60 ppm of testosterone undecanoate spiked sample. Precision and intermediate precision showed that % RSD of test sample solut.. View More»
DOI:
10.4172/2329-6631.1000184