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

被引：1
|
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
收藏
页码：327 / 333
页数：7
相关论文
共 50 条
  • [31] Stability Indicating Method Development and Validation for the Estimation of Rotigotine by RP-HPLC in Bulk and Pharmaceutical Dosage Form
    Swarupa, P. Geetha
    Krishna, D. Radha
    Prasad, K. R. S.
    Babu, K. Suresh
    ORIENTAL JOURNAL OF CHEMISTRY, 2015, 31 (04) : 2499 - 2505
  • [32] Development and validation of a stability-indicating method for the simultaneous estimation of cefixime and dicloxacillin using the RP-HPLC method
    Bhinge, Somnath D.
    Malipatil, Sharangouda M.
    JOURNAL OF TAIBAH UNIVERSITY FOR SCIENCE, 2016, 10 (05): : 734 - 744
  • [33] Development and validation of a novel stability indicating RP-HPLC method for the quantitative determination of marbofloxacin in its tablets
    Maheshwari, Priyanka
    Shukla, Neelima
    Dare, Manish Kumar
    JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, 2017, 40 (02) : 93 - 101
  • [34] DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF ANTIRETROVIRAL DRUGS AND THEIR PHARMACEUTICAL FORMULATIONS
    Joshi, Naresh Chandra
    Kumar, Pradeep
    Jat, Rakesh Kumar
    PHARMACOPHORE, 2016, 7 (03): : 152 - 165
  • [35] Development and Validation of Robust, Highly Sensitive and Stability-Indicating RP-HPLC Method for Estimation of Deferasirox and its Degradation Products
    Shishodia, Tarun
    Grover, Parul
    Nagarajan, K.
    Bhardwaj, Monika
    Chopra, Bhawna
    JOURNAL OF CHROMATOGRAPHIC SCIENCE, 2023, 62 (08) : 709 - 718
  • [36] Development and Validation of Stability-Indicating RP-HPLC Method for the Estimation of Lenalidomide and its Impurities in Oral Solid Dosage Form
    Prasad, Somana Siva
    Mohan, G. V. Krishna
    Babu, A. Naga
    ORIENTAL JOURNAL OF CHEMISTRY, 2019, 35 (01) : 140 - 149
  • [37] Development and Validation of Stability Indicating RP-HPLC Method for Pyrimethamine, Sulfadoxine, and Artesunate Estimation in Bulk and Its Formulation Applying DOE
    Dash, Dillip Kumar
    Sen, Ashim Kumar
    ASIAN JOURNAL OF PHARMACEUTICS, 2023, 17 (03) : 412 - 420
  • [38] Development and validation of a new and economical stability indicating RP-HPLC method for cefixime trihydrate
    Mathew, Ceema
    Swathi, Bellamkonda
    Ajitha, Makula
    Babu, Puvvadi Sathesh
    BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2016, 52 (01) : 87 - 94
  • [39] RP-HPLC Stability Indicating Method Development and Validation for Simultaneous Determination of Grazoprevir and Elbasvir
    Aymen Labidi
    Sami Jebali
    Mehdi Safta
    Latifa Latrous El Atrache
    Chemistry Africa, 2021, 4 : 607 - 619
  • [40] RP-HPLC Stability Indicating Method Development and Validation for Simultaneous Determination of Grazoprevir and Elbasvir
    Labidi, Aymen
    Jebali, Sami
    Safta, Mehdi
    El Atrache, Latifa Latrous
    CHEMISTRY AFRICA-A JOURNAL OF THE TUNISIAN CHEMICAL SOCIETY, 2021, 4 (03): : 607 - 619
12345