Novel Validated HPTLC Method for the Analysis of Two Binary Mixtures Containing Tamsulosin Hydrochloride with Antimuscarinic Agents

El-Kimary, Eman I.; Khamis, E.; Belal, Saied; Moneim, Mona M. Abdel

doi:10.1093/chromsci/bmx081

Cited by 27 publications

(9 citation statements)

References 12 publications

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“…It acts by increasing the levels of intracellular cyclic guanosine monophosphate in smooth muscles of the bladder neck and prostate which in turn reduces contractility tone and improves urine flow [15]. On reviewing literature, TMS was quantified by several methods, namely; TLC [16][17][18], HPLC in different matrices [18][19][20][21], capillary electrophoresis [16], spectrophotometry [16,[22][23][24], and electrochemical methods [16,25]. For TAD, several methods were reported for its determination includ-ing TLC [26][27][28][29], HPLC [26,[30][31][32][33][34][35][36], gas chromatography [26,37], capillary electrophoresis [26], spectrophotometry [26,[38][39][40][41], and electrochemical methods [42][43][44].…”

Section: Introductionmentioning

confidence: 99%

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Rezk

Abdel-Moety

Wadie

et al. 2020

J of Separation Science

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The advent of a new pharmaceutical formulation evokes the need for examining the chemical stability of their constituents and establishing proper stability‐indicating methods. Herein, the stability of the newly co‐formulated Tamsulosin and Tadalafil were examined under different stress conditions. The acidic degradation of Tamsulosin yielded its sulfonated derivative, while Tadalafil was susceptible to both acidic and basic degradation. Two stability‐indicating chromatographic methods, namely; high‐performance thin‐layer chromatography and high‐performance liquid chromatography, have been developed. Significant high‐performance thin‐layer chromatography‐fractionation could be achieved by utilizing a stationary phase of silica gel 60 F254 and a mobile phase composed of ethyl acetate/toluene/methanol/ammonia (4:2:4:0.6, by volumes) with densitometric recording at 280 nm over a concentration range of 0.5–25 μg/band for both drugs. The HPLC‐separation could be reached on XBridge® C18 column isocraticaly by using a mobile phase having acetonitrile/phosphate buffer, pH 6.0 (45:55, v/v) pumped at a flow rate of 1.7 mL/min and applying diode array ultraviolet‐detection at 210 nm over a linearity range of 3–70 μg/mL for each drug. Specificity of the two methods was additionally assured via peak purity assessment. Moreover, the methods were distinctly exploited for evaluating the drugs’ stability in accelerated stability‐studied samples of Tamplus® capsules.

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Section: Introductionmentioning

confidence: 99%

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Rezk

Abdel-Moety

Wadie

et al. 2020

J of Separation Science

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“…As far as we know, there are just a few methods for determining TAM and SLF that have been published as synchronous emission spectrofluorimetric method [24], HPTLC [25] RP-HPLC methods [26,27], and spectrophotometric methods [28,29].…”

Section: Introductionmentioning

confidence: 99%

Two green chromatographic methods for the quantification of tamsulosin and solifenacin along with four of their impurities

Kamel

2022

J of Separation Science

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Modern analytical procedures often include impurity profiling to verify the potency, safety, and effectiveness of new formulations. We had to develop techniques based on green analysis since the detrimental influence of solvents and chemicals on the environment has now become a serious concern. Two selective, sensitive, and green liquid chromatography methods were established and fully validated for quantitation of tamsulosin hydrochloride and solifenacin succinate along with four of their official and/or related impurities namely; tamsulosin sulfonic acid, tamsulosin impurity H, solifenacin impurity A and solifenacin impurity C. The first used high‐performance thin‐layer chromatography with silica gel 60 F254 plates as the stationary phase and an elution system of ethyl acetate:butanol:glacial acetic acid (10.0:0.4:0.1, by volume) and a scanning wavelength of 225.0 nm. The second method depended on HPLC with diode array detection. Chromatographic separation was accomplished on a Zorbax SB C18 (250 × 4.6 mm2, 5 μm) column utilizing a mixture of 10.0 mM sodium dihydrogen phosphate (pH 3.0, adjusted by o‐phosphoric acid) and methanol, at a flow rate of 0.8 mL/min in a gradient elution mode and then the separated peaks were scanned at a wavelength of 225.0 nm. To assess the greenness profile, three distinct methodologies were applied.

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“…7 Compared with these reported chromatographic techniques, High Performance Thin Layer Chromatography (HPTLC) shows the advantages of low expenses, simplicity of performance, and possibility of running several samples in the same run using small amount of solvents making it more ecofriendly. 8,9 It is advantageous in increasing sample throughput and the ease of comparison of the spots positions with those of reference standards analyzed simultaneously. 10 Application of TLC for the resolution of some β-blockers' enantiomers (other than BET, CAR, and SOT) has been performed using plates impregnated with different chiral selectors [11][12][13][14] and one TLC report 3 for the separation of CAR using impregnated silica plates but no reports on enantiomeric separation or quantification of BET and SOT by HPTLC.…”

Section: Introductionmentioning

confidence: 99%

Box‐Behnken response surface modeling assisted enantiomeric resolution of some racemic β‐blockers using HPTLC and β‐cyclodextrin as chiral mobile phase additive: Application to check the enantiomeric purity of betaxolol

El-Kimary

Ragab

2018

Chirality

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Stereospecific separation method of (±) betaxolol, (±) carvedilol, and (±) sotalol using High Performance Thin Layer Chromatography (HPTLC) and β-cyclodextrin as chiral selector has been developed and validated. The Box-Behnken surface response design was selected for optimizing the operating variables based on 15 trials design. The optimized method involves separation on Fluka HPTLC silica gel plates 60 F (20 × 10 cm) using acetonitrile-methanol-acetic acid-water (3.4:3.6:0.18:1 v/v) as a mobile phase containing 0.57 mM β-cyclodextrin. Densitometric measurements were made at 220 nm for betaxolol and sotalol or at 245 nm for carvedilol. Maximum separation of the enantiomers of the three drugs was obtained by optimizing concentration of chiral selector, the mobile phase composition including acetonitrile amount in the organic part of the mobile phase and the volume of acetic acid added. The proposed method enables estimation of (-) and (+) enantiomers of betaxolol in drug substance and in various pharmaceuticals. The detection limit of betaxolol was 0.15 and 0.13 μg band for (-) and (+) enantiomers, respectively. The detection limits were found to be 0.2 and 0.3 μg band for carvedilol and sotalol, respectively, as racemate. In addition, the proposed method was applied in checking the enantiomeric purity of (-) BET in the presence of (+) BET at 1% level where the inactive (+) enantiomer was quantified with good accuracy and precision at 1% level in the active (-) enantiomer.

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Novel Validated HPTLC Method for the Analysis of Two Binary Mixtures Containing Tamsulosin Hydrochloride with Antimuscarinic Agents

Cited by 27 publications

References 12 publications

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Two green chromatographic methods for the quantification of tamsulosin and solifenacin along with four of their impurities

Box‐Behnken response surface modeling assisted enantiomeric resolution of some racemic β‐blockers using HPTLC and β‐cyclodextrin as chiral mobile phase additive: Application to check the enantiomeric purity of betaxolol

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