Simultaneous determination of tolterodine and its two metabolites, 5-hydroxymethyltolterodine and N-dealkyltolterodine in human plasma using LC–MS/MS and its application to a pharmacokinetic study

Kim, Young-Hoon; Byeon, J.Y.; Kim, Se-Hyung; Lee, Choong-Min; Jung, Eui Hyun; Chae, Won Ki; Jang, Choon‐Gon; Lee, Seok‐Yong; Lee, Yun Jeong

doi:10.1007/s12272-017-0981-3

Cited by 5 publications

(1 citation statement)

References 17 publications

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“…It is chemically 2-[(1R)-3-[di (propan-2-yl) amino]-1-phenyl propyl]-4-methyl phenol ( Figure 1) [11]. Few chromatographic [12][13][14][15], spectrophotometric [16][17][18], spectroflurometric [19], and electrochemical [20] methods have been reported also for determination of tolterodine either alone or in combination with other drugs other than tamsulosin.…”

Section: Introductionmentioning

confidence: 99%

Untitled

2018

AJC

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A rapid, sensitive and accurate ultra-performance reversed phase liquid chromatographic method was developed for the simultaneous determination of tamsulosin and tolterodine in pure form and pharmaceutical preparation. The developed UPLC method is superior to conventional HPLC with respect to speed, resolution, solvent consumption and cost. The separation was carried out on RP C 18 nucleosil (1.7 µm, 5 cm x 2 mm) using an isocratic mode in eluting Tamsulosin and Tolterodine at 1.54 min and 2.43 min respectively with a mobile phase composed of acetonitrile and 0.025N potassium phosphate buffer pH 3.50 (60%:40%), respectively. Chromatographic run time was 5 min with a flow rate 0.5 ml/min and UV detection at 220 nm. The linearity for tamsulosin and tolterodine were in the range of 2-20 µg/mL for both drugs, showed excellent recoveries for bulk and tablet dosage form with a very low LOD of 4.29 and 0.59 ng/mL for tamsulosin and tolterodine, respectively. The method has been validated for linearity, accuracy, precision, specificity, and limit of detection, limit of Quantification, robustness, and ruggedness. The method which was developed was validated as per the ICH guidelines. Finally, the method was compared statistically with reference methods indicating that there is no significant difference between them in respect of precision and accuracy.

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Section: Introductionmentioning

confidence: 99%

Untitled

2018

AJC

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Simultaneous ultra-sensitive analysis of tamsulosin hydrochloride and tolterodine tartrate binary mixture in their dosage form via high-performance thin-layer chromatography with fluorimetric detection

Rizk

Mahmoud

Azab

2022

JPC-J Planar Chromat

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A simple, sensitive, selective, and stability-indicating high-performance thin-layer chromatography method with fluorescence detection was developed for the analysis of a mixture of tamsulosin hydrochloride and tolterodine tartrate, used in the management of benign prostatic hyperplasia in their laboratory-prepared binary mixture and dosage form. The separation was employed on thin-layer chromatography silica gel 60 aluminum sheets. As developing system, ethyl acetate–n-hexane–diethylamine (9:3:1, V/V) was used. Tamsulosin and tolterodine had retention factors (RF) of 0.40 ± 0.03 and 0.85 ± 0.03, respectively. A 225 nm excitation wavelength was used for the fluorescence detection. Linearity was in the range of 10.0–200.0 and 100.0–900.0 ng/band for tamsulosin and tolterodine, respectively. The method was validated successfully according to the International Council for Harmonisation guidelines. Our suggested method for determining tamsulosin and tolterodine in their dosage forms and in the presence of their degradation products could be conveniently applied in quality-control laboratories.

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Inhibition of salivary secretion by tolterodine transdermal patch

Byeon

Kim

et al. 2017

Arch. Pharm. Res.

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Tolterodine, a nonselective muscarinic antagonist available only as immediate release (IR) or extended release (ER) oral formulations, is used for the treatment of overactive bladder (OAB). This study aimed to compare the efficacy and extent of dry mouth adverse effects of tolterodine transdermal patch to the oral formulation. The two formulations have been examined through the muscarinic receptor binding tests conducted in bladder and salivary gland tissues and the salivary secretion tests conducted in rats. Comparable average tolterodine blood concentration levels were obtained 3 h after oral administration of tolterodine 25 mg/kg and 12 h after transdermal application of tolterodine patch 6 mg/8 cm. While K in the bladder tissue increased to a similar degree in both formulations of tolterodine, K in the salivary gland increased to a greater degree in the oral formulation. These results indicate that similar degree of inhibitory effects were observed in the bladder for both formulations while less inhibitory effects were observed in the salivary gland with tolterodine transdermal formulation compared to the oral formulation. For assessment of salivary secretion, tolterodine transdermal patch 6 mg/8 cm application resulted in significantly less inhibitory effects than oral tolterodine 25 mg/kg. Therefore, this study suggests that tolterodine transdermal patch could be a useful formulation that provides uniform and consistent inhibitory effects to effectively control OAB symptoms with reduced severity of dry mouth in comparison to the oral formulation.

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Simultaneous determination of tolterodine and its two metabolites, 5-hydroxymethyltolterodine and N-dealkyltolterodine in human plasma using LC–MS/MS and its application to a pharmacokinetic study

Cited by 5 publications

References 17 publications

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Simultaneous ultra-sensitive analysis of tamsulosin hydrochloride and tolterodine tartrate binary mixture in their dosage form via high-performance thin-layer chromatography with fluorimetric detection

Inhibition of salivary secretion by tolterodine transdermal patch

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