Selective and rapid determination of tadalafil and finasteride using solid phase extraction by high performance liquid chromatography and tandem mass spectrometry

Nagaraju, P.; Kodali, Balaji

doi:10.1016/j.jpba.2018.01.020

Cited by 16 publications

(14 citation statements)

References 29 publications

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“…For analysis of the samples, liquid chromatography with tandem mass spectrometry was used [36]. This method was also validated for TDL quantitation in the rat prostates.…”

Section: Chromatographic Analysis Of Tdl Quantitation In Rat Prostatesmentioning

confidence: 99%

RETRACTED: Attenuation of Benign Prostatic Hyperplasia by Optimized Tadalafil Loaded Pumpkin Seed Oil-Based Self Nanoemulsion: In Vitro and In Vivo Evaluation

2019

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The FDA has approved tadalafil (TDL) for the treatment of benign prostatic hyperplasia (BPH)-associated symptoms. Pumpkin seed oil (PSO) has shown promise for the relief of prostatitis-related lower urinary tract symptoms. The aim was to improve TDL delivery to the prostate and assess the combined effect of TDL with a PSO-based formula in the management of BPH. PSO, Tween 80, and polyethylene glycol 200 were selected for the optimization of self nano-emulsified drug delivery system (SNEDDS). The formed vesicles were assessed for their globule size and zeta potential. A rat in vivo study was carried out to investigate prostate weight and index, histopathology, and pharmacokinetics. The average globule size for the optimized TDL-PSO SNEDDS was 204.8 ± 18.76 nm, with a zeta-potential value of 7.86 ± 1.21 mV. TDL-PSO SNEDDS produced a marked drop in prostate weight by 35.51% and prostate index by 36.71% compared to the testosterone-only group. Pharmacokinetic data revealed a 2.3-fold increase of TDL concentration, from optimized TDL-PSO SNEDDS, in the prostate compared with the raw TDL group. This study indicated that the combination of TDL and PSO in an optimized TDL PSO SNEDDS formula improved the efficacy of TDL in the management of BPH.Pharmaceutics 2019, 11, 640 2 of 13 PDE5 also elevates the amount of blood reaching the lower urinary tract, while influencing the afferent nerve activity of the bladder [5,9,10]. Moreover, bladder performance can be impacted by functional and structural variations in the prostate, bladder, and the vasculature supporting such structures [11]. This elevation in cGMP concentration results in an efflux of calcium and relaxation of the SMCs. Several processes may aid in the alleviation of lower urinary tract symptoms (LUTS) and can be facilitated by PDE5 isoenzyme inhibition in the lower part of the urinary tract [4]. Altogether, the administration of 5 mg of tadalafil (TDL) in a daily manner led to significantly better results compared to the placebo. The safety profile of TDL was promising, and TDL was found to be well-tolerated [1,12]. Thus, the findings of these studies supported administering TDL 5 mg once a day as a treatment for benign LUTS suggestive of BPH [1,12,13]. TDL (5 mg) was approved by the FDA to be taken once a day for the treatment of LUTS symptoms linked to BPH. A randomized, double-blind, placebo-controlled, parallel design study using 2.5 mg of TDL over 12 weeks indicated improvements in the international prostate symptom score (IPSS) [14]. TDL increased pelvic perfusion by up-regulating NO and cGMP, which reduced the prostatic ischemia and improved the blood circulation.Pumpkin seed oil (PSO) is a part of the Cucurbitaceae family that has demonstrated excellent potential for the treatment of nocturia, urinary incontinence, and the frequency of urination in clinical trials [9]. PSO's chemical composition includes fatty acids, tocopherols, and phytosterols, in addition to squalene (triterpene). The main fatty acids that constitute about 90% of PSOs are palmitic aci...

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“…For analysis of the samples, liquid chromatography with tandem mass spectrometry was used [36]. This method was also validated for TDL quantitation in the rat prostates.…”

Section: Chromatographic Analysis Of Tdl Quantitation In Rat Prostatesmentioning

confidence: 99%

RETRACTED: Attenuation of Benign Prostatic Hyperplasia by Optimized Tadalafil Loaded Pumpkin Seed Oil-Based Self Nanoemulsion: In Vitro and In Vivo Evaluation

2019

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“…Rare instances of IV immunoglobulin infusion, particularly in the neonatal setting, have been reported to produce transient hyperviscosity requiring therapeutic intervention. 20,21 Causes of hyperviscosity are listed in Table 1.…”

Section: Clinical Syndromes Associated With Serum Hyperviscositymentioning

confidence: 99%

Acute hyperviscosity: syndromes and management

Gertz

2018

Blood

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Plasma hyperviscosity is a rare complication of both monoclonal and polyclonal disorders associated with elevation of immunoglobulins. Asymptomatic patients with an elevation in the serum viscosity do not require plasma exchange, and the majority will have other indications for therapeutic intervention. For patients with hemorrhagic or central nervous system manifestations, plasma exchange is the therapy of choice and is relatively safe. Viscosity measurements are not required to initiate therapy if the index of suspicion is high and the clinical presentation is typical. However, patients should have a sample sent for confirmation of the diagnosis. Whole-blood hyperviscosity is seen in patients with extreme elevation of the red cell and white cell count. Phlebotomy of patients with primary and secondary elevation of the red cell count is a well-established therapy.

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“…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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Selective and rapid determination of tadalafil and finasteride using solid phase extraction by high performance liquid chromatography and tandem mass spectrometry

Cited by 16 publications

References 29 publications

RETRACTED: Attenuation of Benign Prostatic Hyperplasia by Optimized Tadalafil Loaded Pumpkin Seed Oil-Based Self Nanoemulsion: In Vitro and In Vivo Evaluation

RETRACTED: Attenuation of Benign Prostatic Hyperplasia by Optimized Tadalafil Loaded Pumpkin Seed Oil-Based Self Nanoemulsion: In Vitro and In Vivo Evaluation

Acute hyperviscosity: syndromes and management

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

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