LC-MS/MS method for simultaneous estimation of raloxifene, cladrin in rat plasma: application in pharmacokinetic studies

被引:4
作者
Chauhan, Divya [1 ,2 ]
Dadge, Shailesh [1 ,2 ]
Yadav, Pavan K. [1 ,2 ]
Sultana, Nazneen [1 ]
Agarwal, Arun [1 ,2 ]
Vishwakarma, Sachin [1 ]
Rathaur, Shivam [1 ]
Yadav, Shubhi [1 ]
K Chourasia, Manish [1 ,2 ]
Gayen, Jiaur R. [1 ,2 ]
机构
[1] Cent Drug Res Inst, Div Pharmaceut & Pharmacokinet, Lucknow 226031, Uttar Pradesh, India
[2] Acad Sci & Innovat Res, Ghaziabad 201002, India
关键词
bioanalytical method validation; co-estimation; LC-MS/MS; pharmacokinetics; raloxifene and cladrin; simultaneous identification; ESTROGEN-RECEPTOR MODULATORS; UPLC-MS/MS; VALIDATION; OSTEOPOROSIS; METABOLITES; ASSAY;
D O I
10.4155/bio-2023-0206
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Aim: A newer LC-MS/MS method was developed and validated for the simultaneous quantification of raloxifene (RL) and cladrin (CL). Methodology: Both drugs were resolved in RP-18 (4.6 x 50 mm, 5 mu) Xbridge Shield column using acetonitrile and 0.1% aqueous solution of formic acid (FA) (70:30% v/v) as mobile phase by using biological matrices in female Sprague-Dawley rats using-MS/MS. Results: The developed method was found to be linear over the concentration ranges of 1-600 ng/ml, and lower limit of quantification was 1 ng/ml for RL and CL, respectively. Pharmacokinetic results of RL+CL showed C-max = 4.23 +/- 0.61, 26.97 +/- 1.14 ng/ml, at T-max(h) 5.5 +/- 1.00 and 3.5 +/- 1.00, respectively. Conclusion: Pharmacokinetic study results will be useful in the future for the combined delivery of RL and CL for osteoporosis treatment. [GRAPHICS] .
引用
收藏
页码:141 / 153
页数:14
相关论文
共 42 条
  • [11] Gujar AV., 2017, J PHARM TECHNOL RES, V5, P41
  • [12] Pharmacokinetics of raloxifene and its clinical application
    Hochner-Celnikier, D
    [J]. EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY, 1999, 85 (01) : 23 - 29
  • [13] Osteoprotegerin, RANKL and bone turnover in postmenopausal osteoporosis
    Jabbar, Suhair
    Drury, John
    Fordham, John N.
    Datta, Harish K.
    Francis, Roger M.
    Tuck, Stephen P.
    [J]. JOURNAL OF CLINICAL PATHOLOGY, 2011, 64 (04) : 354 - 357
  • [14] Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics
    Jenkins, Rand
    Duggan, Jeffrey X.
    Aubry, Anne-Francoise
    Zeng, Jianing
    Lee, Jean W.
    Cojocaru, Laura
    Dufield, Dawn
    Garofolo, Fabio
    Kaur, Surinder
    Schultz, Gary A.
    Xu, Keyang
    Yang, Ziping
    Yu, John
    Zhang, Yan J.
    Vazvaei, Faye
    [J]. AAPS JOURNAL, 2015, 17 (01): : 1 - 16
  • [15] Phosphodiesterase: overview of protein structures, potential therapeutic applications and recent progress in drug development
    Jeon, YH
    Heo, YS
    Kim, CM
    Hyun, YL
    Lee, TG
    Ro, S
    Cho, JM
    [J]. CELLULAR AND MOLECULAR LIFE SCIENCES, 2005, 62 (11) : 1198 - 1220
  • [16] SERMs: Meeting the promise of multifunctional medicines
    Jordan, V. Craig
    [J]. JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2007, 99 (05): : 350 - 356
  • [17] Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry
    Kadian, Naveen
    Raju, Kanumuri Siva Rama
    Rashid, Mamunur
    Malik, Mohd Yaseen
    Taneja, Isha
    Wahajuddin, Muhammad
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2016, 126 : 83 - 97
  • [18] Positive skeletal effects of cladrin, a naturally occurring dimethoxydaidzein, in osteopenic rats that were maintained after treatment discontinuation
    Khan, K.
    Sharan, K.
    Swarnkar, G.
    Chakravarti, B.
    Mittal, M.
    Barbhuyan, T. K.
    China, S. P.
    Khan, M. P.
    Nagar, G. K.
    Yadav, D.
    Dixit, P.
    Maurya, R.
    Chattopadhyay, N.
    [J]. OSTEOPOROSIS INTERNATIONAL, 2013, 24 (04) : 1455 - 1470
  • [19] Current and Future Incidence and Costs of Osteoporosis-Related Fractures in The Netherlands: Combining Claims Data with BMD Measurements
    Lotters, Freek J. B.
    van den Bergh, Joop P.
    de Vries, Frank
    Rutten-van Molken, Maureen P. M. H.
    [J]. CALCIFIED TISSUE INTERNATIONAL, 2016, 98 (03) : 235 - 243
  • [20] Bioanalytical method development and validation: Critical concepts and strategies
    Moein, Mohammad Mandi
    El Beqqali, Aziza
    Abdel-Rehim, Mohamed
    [J]. JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2017, 1043 : 3 - 11