Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Larotrectinib in its Formulations

被引：2

作者：

Fatima, Mahreen ^{[1
]}

Koneru, Anupama ^{[2
]}

Khan, M. Mushraff Ali ^{[3
]}

Varanasi, Murali Balaram ^{[1
]}

Syed, Imam Pasha ^{[1
]}

机构：

[1] Sultan Ul Uloom Coll Pharm, Dept Pharmaceut Qual Assurance, 8-2-249,Rd 3, Hyderabad 500034, Telangana, India

[2] Sultan Ul Uloom Coll Pharm, Dept Pharmacol, 8-2-249,Rd 3, Hyderabad 500034, Telangana, India

[3] Sultan Ul Uloom Coll Pharm, Dept Pharmaceut, 8-2-249,Rd 3, Hyderabad 500034, Telangana, India

来源：

ORIENTAL JOURNAL OF CHEMISTRY | 2020年 / 36卷 / 02期

关键词：

HPLC; Larotrectinib; Method development; ICH Guidelines; FUSION;

D O I：

10.13005/ojc/360216

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

A stability indicating HPLC method for the quantification of Larotrectinib in capsule form was developed and validated as per the ICH guidelines. Separation and quantification of Larotrectinib was carried out on column Sunsil C-18 using mobile phase as KH2PO4 and methanol in 1:1 ratio. Larotrectinib was eluted at 3.432 minutes. Linearity was observed in between 50-150 mu g/ml. LOD and LOO were found to be 0.065 mu g/ml and 0.217 mu g/ml respectively. % RSD for the precision of the method was found to be 0.115. Accuracy was well within the regulated limit that is 100.13% and the recovery was found to be to 100.47%. Forced degradation analysis was carried out on Larotrectinib which established stability indicating power of the developed method.

引用

页码：327 / 333

页数：7

共 23 条

[1]

Akram NM, 2017, ORIENT J CHEM, V33, P1492, DOI 10.13005/ojc/330354

[2]

[Anonymous], 1996, METH FED REG, V60, P27464

[3] Neurotrophin signaling:: many exciting surprises! [J].

Arevalo, J. C. ;

Wu, S. H. .

CELLULAR AND MOLECULAR LIFE SCIENCES, 2006, 63 (13) :1523-1537

[4]

Berger Stephanie, 2018, Recent Results Cancer Res, V211, P141, DOI 10.1007/978-3-319-91442-8_10

[5] Neurotrophins and their receptors: A convergence point for many signalling pathways [J].

Chao, MV .

NATURE REVIEWS NEUROSCIENCE, 2003, 4 (04) :299-309

[6]

Geetha M., 2013, ORIENT J CHEM, V29, P579, DOI DOI 10.13005/ojc/290227

[7] Phase II randomised trial comparing docetaxel given every 3 weeks with weekly schedule as second-line therapy in patients with advanced non-small-cell lung cancer (NSCLC) [J].

Gervais, R ;

Ducolone, A ;

Breton, JL ;

Braun, D ;

Lebeau, B ;

Vaylet, F ;

Debieuvre, D ;

Pujol, JL ;

Tredaniel, J ;

Clouet, P ;

Quoix, E .

ANNALS OF ONCOLOGY, 2005, 16 (01) :90-96

[8]

Heidurnezhad Z., 2013, ORIENT J CHEM, V29, P69

[9] Larotrectinib in adult patients with solid tumours: a multi-centre, open-label, phase I dose-escalation study [J].

Hong, D. S. ;

Bauer, T. M. ;

Lee, J. J. ;

Dowlati, A. ;

Brose, M. S. ;

Farago, A. F. ;

Taylor, M. ;

Shaw, A. T. ;

Montez, S. ;

Meric-Bernstam, F. ;

Smith, S. ;

Tuch, B. B. ;

Ebata, K. ;

Cruickshank, S. ;

Cox, M. C. ;

Burris, H. A., III ;

Doebele, R. C. .

ANNALS OF ONCOLOGY, 2019, 30 (02) :325-331

[10]

ICH Expert Working Group, 1995, FED REGISTER, V60, P11260

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