Abstract
A TLC densitometric method was developed and validated for simultaneous determination of dutasteride and tamsulosin in their challenging combined pharmaceutical formulation, where the separation process was achieved using a mobile phase composed of ethyl acetate: methanol: hexane: ammonia (90: 5: 3: 2 by volume) on pre-coated silica gel (60 GF254) plates, densitometric quantification was performed at 270 nm for both drugs. TAMS and DUTA were resolved with Rf values of 0.57± 0.01 and 0.72 ± 0.01 with a mean percentage recovery of 100.51 ± 0.659 and 100.81 ± 0.743, respectively. Method validation was performed following the International Conference on Harmonization (ICH) guidelines and was victoriously applied for simultaneous determination of tamsulosin HCl and dutasteride in their pharmaceutical formulation. The acquired results of the Proposed method were statistically compared with those acquired by the reported methods, demonstrating no significant difference. Therefore, the proposed method has the potential for being fast, simple, economic, and selective for sustainable analysis of the cited drugs.
Highlights
Nowadays, benign prostatic hyperplasia (BPH) is the most prevailing urological disease in men after middle age (Foo, 2019)
The Combination therapy with tamsulosin and dutasteride is more effective than monotherapy with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia and prostatic enlargement (Roehrborn et al, 2010)
The sensitivity of the suggested methods is determined by calculating the limit of detection (LOD) and limit of quantitation (LOQ). they were calculated according to International Conference on Harmonization (ICH) guidelines by an approach based on the standard deviation of the response and the slope
Summary
Benign prostatic hyperplasia (BPH) is the most prevailing urological disease in men after middle age (Foo, 2019). The Combination therapy with tamsulosin and dutasteride is more effective than monotherapy with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia and prostatic enlargement (Roehrborn et al, 2010). It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether (Dunn et al, 2002). It is a selective α1-adrenoreceptor blocking agent prescribed for improving urinary obstruction and alleviate the symptoms of benign prostatic hyperplasia by preventing the sympathetic excitation of smooth muscle tone in the prostate and bladder neck
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