Author(s): Anupam Sharma, Amar Deep Ankalgi, Arti Devi, Vinay Pandit, Mahendra Singh Ashawat

Email(s): anu105009@gmail.com

DOI: 10.52711/2231-5675.2021.00014   

Address: Anupam Sharma*, Amar Deep Ankalgi, Arti Devi, Vinay Pandit, Mahendra Singh Ashawat
Department of Pharmaceutical Analysis and Quality Assurance, Laureate Institute of Pharmacy, VPO Kathog, Jawalamukhi, Himachal Pradesh - 176031, India.
*Corresponding Author

Published In:   Volume - 11,      Issue - 2,     Year - 2021


ABSTRACT:
A rapid isocratic chromatographic procedure for the analysis of methotrexate, hydroxychloroquine sulfate in bulk drug and pharmaceutical formulations was developed validated in the present study. The mobile phase consists of a mixture of Water: Acetonitrile: Tetrahydrofuran in the proportion of 50:40:10 and pH maintained to 3with perchloric acid. Retention time was found to be 3.0 and 3.7minutes for methotrexate and hydroxychloroquine sulfate respectively. The method was performing by using the C18 column, ODS Hypersil column with UV detection at 318nm, and flow rate of 1.0ml/min. The percentage of recovery for both drugs was found to be 99.99%. All validation parameters were within limits as per the ICH guidelines.


Cite this article:
Anupam Sharma, Amar Deep Ankalgi, Arti Devi, Vinay Pandit, Mahendra Singh Ashawat. Analytical Method Development and Validation for Simultaneous estimation of Methotrexate and Hydroxychloroquine sulfate in bulk drug by using RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):73-8. doi: 10.52711/2231-5675.2021.00014

Cite(Electronic):
Anupam Sharma, Amar Deep Ankalgi, Arti Devi, Vinay Pandit, Mahendra Singh Ashawat. Analytical Method Development and Validation for Simultaneous estimation of Methotrexate and Hydroxychloroquine sulfate in bulk drug by using RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):73-8. doi: 10.52711/2231-5675.2021.00014   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-2-4


REFERENCES:
1.    Braun J. Methotrexate: Optimizing the Efficacy in Rheumatoid Arthritis. Ther Adv Musculoskelet Dis; 2011. 151-158.
2.    HJ Williams, JR Ward, JC Reading, Comparison of auranofin, methotrexate, and the combination of both in the treatment of rheumatoid arthritis. A controlled clinical trial; a journal of the national library of medicine; 1992; 35(3): 259-69.
3.    ICH Harmonized Tripartite Guidelines, Validation of Analytical Procedure: Text and Methodology Q2 (R1), Current Step 4 Version, Parent Guidelines on Methodology; 2005. 1-13
4.    Sethi PD, Sethi R. Sethi's, HPLC: High-Performance Liquid Chromatography; Quantitative Analysis of Pharmaceutical Formulations. CBS Publ; 2010.
5.    Sartori T, Murakami FS, Development and Validation of a Fast RP-HPLC Method for Determination of Methotrexate Entrapment Efficiency in Polymeric Nanocapsules; Journal of Chromatographic Science, 2008; 46(6).505-509.
6.    Mobil A, S Rezaee. High-Performance Liquid Chromatography Determination of Methotrexate in Plasma; Iranian Journal of Pharmaceutical Research, 2003; 2(3). 149-152.
7.    Suguna P, Sathyanarayana B, Validation of HPLC Method for the Analysis of Methotrexate in Bulk Drug and Pharmaceutical Dosage Forms. Journal of Chemical and Pharmaceutical Research, 2015; 7(9). 27-35.
8.    Montemurro M, Maria MD. Optimized High-Performance Liquid Chromatography–Ultraviolet Detection Method Using Core-Shell Particles for the Therapeutic Monitoring of Methotrexate; Journal of Pharmaceutical Analysis, 2016; 6(2). 103-111.
9.    Roy M, Mukesh M.  Development and Validation of RP- PLC Method for the Determination of Methotrexate in Bulk and Pharmaceutical Tablet Dosage, European Journal of Pharmaceutical and Medical Research, 2016; 3(5). 355-358
10.    Agnihotri J, Singh S. Simultaneous Estimation of Antimalarial Drugs Artesunate and Hydroxychloroquine by Validated HPLC Method in Combined Pharmaceutical Formulation. Indo American Journal of Pharmaceutical Research, 2013; (6). 177-122.
11.    Karuppiah SP, Basha AK. Analytical Method Development for Impurities Present in Hydroxychloroquine Sulphate from Antimalarial Tablet Formulation. World Journal of Pharmacy and Pharmaceutical Sciences, 2014; 3(7). 586–591.
12.    Singh A, Singh CL, Development, and Validation of Reversed-Phase High-Performance Liquid Chromatography Method for Hydroxychloroquine Sulfate. Indian J Pharm Sci, 2015; 77(5). 586-590.
13.    McCrudden EA, Tett SE. Improved high-performance liquid chromatography determination of methotrexate and its major metabolite in plasma using a poly (styrene-divinylbenzene) column. J Chromatog B, 1999; (721). 87–92.
14.    S.JanetBeula,Dr.R.Suthakaran,PremKumarBichala, CH. Shankar, Syed Ghouse, K. Suneetha. A Prospective Validation of Hydrochlorothiazide and Bisoprolol Fumerate in its Pure and Bulk Dosages Forms by using RP-HPLC Technique .Asian J.Pharma.Ana.2020;10(1): 01-06.
15.    B.Bhavya, P.Nagaraju, V.Mounika, G. Indira Priyadarshini. Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Albendazole and lvermectin in Pharmaceutical Dosage form. Asian J. Pharm. Ana.2017; 7(1) 6-14.
16.    Sushil D. Patil, Sunil V. Amurutkar, C. D. Upasani. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian J. Pharm. Ana. 2016;6(4): 201-206
17.    Kirthi A,Shanmugam R,Mohana LakshmiS,Ashok Kumar CK,Padmini K,Shanti Prathyusha M,Shilpa V.Analytical Method Development of a Stability-indicating RP-HPLC Method for the Analysis of Danazol in Pharmaceutical Dosage Form.  Asian J. Pharm. Ana. 2016;6(4): 227-234.
18.    Kumaraswamy.Gandla, D.Sudheer Kumar, Joru Praveen, Emmadi Suman. RP-HPLC Method Development and Validation for Simultaneous Estimation of Lignocaine Hydrochloride and Clotrimazole Hydrochloride in Ear Drops. Asian J. Pharm. Ana. 2017; 7(3): 163-168
19.    A New Analytical method Validation and Quantification of Entacapone and its Related Substance in bulk G. Kumar, T. B. Patrudu, Tentu Nageswara Rao, M. V. Basaveswara Rao. Drug Product by HPLC. Asian J. Pharm. Ana. 2017; 7(1)1-5.
20.    Jayshree Pawar, Sandeep Sonawane, Santosh Chhajied, Sanjay Kshirsagar. Development and Validation of RP-HPLC method for simultaneous Estimation of Metformin HCl and Gliclazide.Asian J.Pharm.Ana.2016;6(3): 151-154.
21.    Prashanthi. Y, Tentu Nageswara Rao, Yellapu Srinivas. Method Development and Validation of Alectinib Drug by RP-HPLC in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2018;8(4):186-190.
22.    B.Thangabalan, M.Salomi, N.Sunitha, S. Manohar Babu. Development of validated RP-HPLC method for the estimation of Itraconazole in pure and pharmaceutical dosage form .Asian J.Pharm.Ana.2013; 3(4): 119-123.
23.    B.Premkuma.Antioxident Defense and Disease activity in Rheumatoid Arthritis.Research J.Pharm.and tech 2018; 11(5): 1810-1814.
24.    Kumaraswamy. Gandla, D. Sudheer Kumar, Joru Praveen, Emmadi Suman. RP-HPLC Method Development and Validation for Simultaneous Estimation of Lignocane Hydrochloride and Clotrimazole Hydrochloride in Ear Droos. Asian J. Pharm. Ana. 2017; 7(3):163-168.
25.    G. Kumaraswamy, M. A. Zeeshan Hamza, R. Suthakaran. Development and validation of RP-HPLC for simultaneous estimation of Cefpodoxime Proxetil and Dicloxacillin Sodium Tablets, Asian J. Pharm.Ana.2014; 4(4).151-155
26.    R. Anusha Naik, Ajay Kumar D., M. Venkatesh. Method development and validation of Taurine and Acetyl Cysteine by using RP-HPLC method, Asian J. Pharm. Ana. 2018; 8(4).223-235
27.    Indian Pharmacopoeia. 6thed.Indian Pharmacopeia Commission Ghaziabad; 2010. 147.

Recomonded Articles:

Author(s): Kirthi A, Shanmugam R, Mohana Lakshmi S , Ashok Kumar CK, Padmini K, Shanti Prathyusha M, Shilpa V

DOI:         Access: Open Access Read More

Author(s): G. Krishnamoorthy, C. Diana Priyadarshini, R. Senthamarai

DOI:         Access: Open Access Read More

Author(s): Hamid Khan, Javed Ali

DOI: 10.5958/2231-5675.2017.00020.5         Access: Open Access Read More

Author(s): Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D

DOI:         Access: Open Access Read More

Author(s): Mansi J. Chaudhari, Suraj R. Chaudhari, Shailesh S. Chalikwar, Atul A. Shirkhedkar

DOI: 10.5958/2231-5675.2018.00008.X         Access: Open Access Read More

Author(s): Khushboo Patel*, Dhara Patel, Jaya Dwivedi, Priyanka Newal, Dhananjay Meshram

DOI: 10.5958/2231-5675.2017.00039.4         Access: Open Access Read More

Author(s): B. Thangabalan, M. Salomi, N. Sunitha, S. Manohar Babu

DOI:         Access: Open Access Read More

Author(s): P. Janaki Pathi, N. Appala Raju, G.Parvathalu

DOI:         Access: Open Access Read More

Author(s): Paras Virani, Rajanit Sojitra, Hasumati Raj, Vineet Jain

DOI: 10.5958/2231-5675.2015.00025.3         Access: Open Access Read More

Author(s): Saroj Kumar Raul, Bukkuru Spandana, Patibandla Sameera, Vegiraju Vikitha

DOI:         Access: Open Access Read More

Author(s): S. Vidyadhara, RLC Sasidhar, B. Venkateswara Rao, P. Ratna Kumari

DOI:         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 

Popular Articles


Recent Articles




Tags