Bio-analytical Method Development and Validation of Tadalafil with a Special Emphasis on Pharmacokinetic Study in Healthy Indian Subjects for the ODS Formulation

Dan, Shubhasis; Halder, Dhiman; Barik, Anwesha; Biswas, Easha; Pal, Murari Mohun; Ghosh, Balaram; Sarkar, Pradipta; Das, Chinmoy; Chakraborty, P. S.; Pradhan, Sangujkta; Pal, Tapan Kumar

doi:10.2174/1573411011666150219203105

Cited by 6 publications

(4 citation statements)

References 8 publications

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“…The extraction was performed by LLE using ethyl acetate and the chromatographic separation was achieved with an isocratic elution consisting of methanol and 10 mM ammonium acetate in water (pH 6.38) (9:1, v/v) at a flow rate of 0.5 ml/min on a Phenomenex Gemini C 18 column. The matrix effect values, tested at low and high concentrations for tadalafil and structurally close analog sildenafil (IS), were within acceptance limits, proving that no co‐eluting substances influenced the responses of both molecules (Dan et al, 2015). Enderle et al (2015) described an LC–MS/MS method for the quantification of ambrisentan, bosentan, sildenafil and tadalafil using DBS extraction from human blood on an FTA DMPK C card.…”

Section: Case Studiesmentioning

confidence: 96%

“…The observed matrix effect was within the acceptance limit and the CV was <17.7% under optimized extraction conditions (Yokoyama et al, 2014). Dan et al (2015) developed and validated a simple LC–MS/MS method to quantify tadalafil in human plasma. The extraction was performed by LLE using ethyl acetate and the chromatographic separation was achieved with an isocratic elution consisting of methanol and 10 mM ammonium acetate in water (pH 6.38) (9:1, v/v) at a flow rate of 0.5 ml/min on a Phenomenex Gemini C 18 column.…”

Section: Case Studiesmentioning

confidence: 99%

See 1 more Smart Citation

A concise review of bioanalytical methods of small molecule immuno‐oncology drugs in cancer therapy

Sulochana

Trivedi

Srinivas³

et al. 2020

Biomedical Chromatography

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Immuno-oncology (IO) is an emerging option to treat cancer malignancies. In the last two years, IO has accounted for more than 90% of the new active drugs in various therapeutic indications of oncology drug development. Bioanalytical methods used for the quantitation of various IO small molecule drugs have been summarized in this review. The most commonly used are HPLC and LC-MS/MS methods. Determination of IO drugs from biological matrices involves drug extraction from the biological matrix, which is mostly achieved by simple protein precipitation, liquid-liquid extraction and solid-phase extraction. Subsequently, quantitation is usually achieved by LC-MS/MS, but HPLC-UV has also been employed. The bioanalytical methods reported for each drug are briefly discussed and tabulated for easy access. Our review indicates that LC-MS/MS is a versatile and reliable tool for the sensitive, rapid and robust quantitation of IO drugs.

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Section: Case Studiesmentioning

confidence: 96%

Section: Case Studiesmentioning

confidence: 99%

A concise review of bioanalytical methods of small molecule immuno‐oncology drugs in cancer therapy

Sulochana

Trivedi

Srinivas³

et al. 2020

Biomedical Chromatography

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“…It was ensured that the volunteers were exposed in both the products (test or reference) during two clinical phases. [21][22][23] 15 days wash-out period was maintained between two clinical phases. Total no of 14 blood samples were collected in 5mL K 2 EDTA vacationers via an indwelling catheter placed in one of the forearm vein for both the study period.…”

Section: Application To a Ba/be Studiesmentioning

confidence: 99%

LC-MS/MS method development and validation of an antihistaminic, calcium channel blocker, di-phenyl-methyl-piperazine group containing cinnarizine in human plasma with an application to BA/BE studies in Indian volunteer

Pal¹,

Dan²,

Bose³

et al. 2018

PPIJ

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Antihistamine is drug which antagonises the action of histamine at the H1 receptors. Qualitatively all H1 antihistaminic have similar actions, but there are quantitative differences, especially in the sedative property. These drugs effectively block the histamine induced bronchoconstriction, contraction of intestinal and smooth muscle and triple response. It also suppressed the immediate or type-I hypersensitivity reaction but certain drugs are effective in preventing motion sickness. Cinnarizine is one of the drugs of antihistaminic medication. It is used to treat problems associated with the inner ear and the brain. The medicine is used to treat dizziness and sickness associated with motion sickness. This drug used in the treatment of vertigo and vestibular disorder and heart and blood vessel disorder. Cinnarizine inhibits the contractions of vascular smooth muscle cells by blocking L-type and T-type voltage gated calcium channel and it also binding to dopamine D2 receptor, histamine H1 receptor and muscarinic acetylcholine receptor. Cinnarizine contain diphenylmethylpiperazine group which protonated precursor ion was 369.3 and product ion 167.2 by using 0.1% formic acid in acetonitrile with 0.1% formic acid containing milli Q water added with 10.mM ammonium acetate as a binary flow. Internal standard precursor ion was 268.2 and product ion was 116.1 as a positive mode. The run time was very short 3.5 min and in between this run time 90% aqueous phase flow upto 0.9 min and 10% upto 2.50 min then again 90% flow upto 3.5 min. This method showed very low matrix effect which calculated matrix factor was 0.87 to 0.94 and recovery was very high 86.88% to 99.57%. So this method was very specific, selective, sensitive and reproducible which used for quantification of cinnarizine concentration of unknown Indian healthy human volunteers from their plasma.

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“…Plasma extraction and sample preparation Plasma extraction was performed by liquid-liquid extraction technique [6]. A 250µl volume of plasma sample was transferred to a 15ml plastic tarson tube.…”

Section: /9mentioning

confidence: 99%

Bioanalytical Method Development and Validation of Letrozole by LC-ESI-MS/MS in Human Plasma

Pal¹

2017

JAPLR

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Letrozole (CAS Number-112809-51-5) is widely used as an oral non-steroidal aromatase inhibitor for the treatment of hormonally-responsive breast cancer after surgery. For quantitation of letrozole, negative polarity was used to achieve adequate response because this was highly sensitive for compounds with high electron affinity. It was applied to fragment the analytes and to obtain intense and consistent product ions. The deprotonated precursor ions [M-H]−at m/z 284.1 was observed in Q1(MS) for letrozole. Characteristic product ions found in Q3(MS) was at m/z 242. 0, 102.1, 126.7, 140.7, 215.1, 240.3 for letrozole. Most stable and consistent fragment ion selected m/z 242.0 having the triazole ring. For the internal standard (tolbutamide) the fragment at Q1 and Q3 having m/z 269.1 and 170.1 was responsible for possessing the methoxyethyl-phenoxy group. In the present study LC-MS/MS-ESI method was attempted to develop for detection and quantification of letrozole in human plasma.Therefore, it can be concluded from the present study findings that developed method by using LC-MS/MS API 2000 and liquid-liquid extraction technique for letrozole in human plasma was found to be simple, specific, sensitive, reproducible and fully validated in according to EMA and USFAD guidelines. The present method was found superior enough to be applied to comparative pharmacokinetic studies in future.

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Bio-analytical Method Development and Validation of Tadalafil with a Special Emphasis on Pharmacokinetic Study in Healthy Indian Subjects for the ODS Formulation

Cited by 6 publications

References 8 publications

A concise review of bioanalytical methods of small molecule immuno‐oncology drugs in cancer therapy

A concise review of bioanalytical methods of small molecule immuno‐oncology drugs in cancer therapy

LC-MS/MS method development and validation of an antihistaminic, calcium channel blocker, di-phenyl-methyl-piperazine group containing cinnarizine in human plasma with an application to BA/BE studies in Indian volunteer

Bioanalytical Method Development and Validation of Letrozole by LC-ESI-MS/MS in Human Plasma

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