STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF TAMSULOSIN HYDROCHLORIDE AND DUTASTERIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORMS
DOI:
https://doi.org/10.48047/Keywords:
Tamsulosin Hydrochloride, Dutasteride, Reverse Phase HPLC, Simultaneous Determination, Forced Degradation.Abstract
A simple, effective, and rapid reverse-phase high-performance liquid chromatographic technique was developed for
the simultaneous determination of TamsulosinHcl and Dutasteride in pure and its pharmaceutical dosage forms. The
method was developed using an X-terra C8 column (4.6 250 mm, 5 m) with a mobile phase that consists of a 60:40
combination ratio of acetonitrile and potassium dihydrogen ortho-phosphate buffer (pH-4.5).The effluents were
monitored at 238 nm at a flow rate of 1 ml/min. TamsulosinHcl and Dutasteride had retention times of 3.15 and
5.625 minutes, respectively. The results of the analysis were statistically validated in accordance with the ICH
norms. TamsulosinHcl and Dutasteride had 99.43 percent and 100.59 percent recovery rates, respectively. A
calibration curve for TamsulosinHcl was plotted, with a range of 8-12 µg/ml and 10-15 µg/ml for Dutasteride.
Accuracy, precision, specificity, robustness, ruggedness, Limit of Detection, Limit of Quantification, and the system
suitability parameters were validated and reported. Forced degradation studies under various conditions like acidic,
basic, thermal, oxidation, and photolysis results were noted and their respective chromatograms of TamsulosinHCl
and Dutasteride were observed, and reported. All of the results were acceptable, indicating that the approach was
suitable for its intended usage in routine quality control and stability studies.
