ISSN

0974-4150 (Online)
0974-4169 (Print)


Author(s): Mohan Seelam, Satyanarayana Purimitla, Nagalakshmi Vedula, Sudheer Kumar Kandukuri, Srinivasa Rao Gundumolu

Email(s): seelam.mohan123@gmail.com

DOI: 10.5958/0974-4150.2021.00005.5   

Address: Mohan Seelam1*, Satyanarayana Purimitla2, Nagalakshmi Vedula3, Sudheer Kumar Kandukuri4, Srinivasa Rao Gundumolu5
1,4Department of Chemistry, Bapatla Engineering College, Bapatla - 522102, Andhra Pradesh, India
2Departments of Chemistry, VRS & YRN College of Engineering and Technology, Chirala - 523155, Andhra Pradesh, India
3,5Department of Chemistry, Ch.S.D. St. Theresa’s College for Women, Eluru-534003, Andhra Pradesh, India
*Corresponding Author

Published In:   Volume - 14,      Issue - 1,     Year - 2021


ABSTRACT:
This study describes the development and validation of reverse phase HPLC method for the estimation of L-Methyl Folate and Tofisopam in combined formulation. The separation was accomplished on a LUNA C18, 250×4.6mm ID, 5µm column connected to a PDA detector using 0.1% ortho phosphoric acid in water as mobile phase A and acetonitrile as mobile phase B, under gradient elution. Mobile phase flow rate was maintained at 1.0 ml/min. The detection of the constituents was done at 234nm using a UV detector. The performance of the method was validated according to the current ICH requirements. LOD and LOQ for all impurities and L-Methyl Folate and Tofisopam were established with respect to the test concentration. Specificity, accuracy, precision, ruggedness and robustness were determined as part of the method validation. All statistical results were within the acceptance criteria and the proposed method is simple, fast, accurate, precise and reproducible hence, it can be applicable for routine analysis for testing chromatographic purity of L-Methyl Folate and Tofisopam.


Cite this article:
Mohan Seelam, Satyanarayana Purimitla, Nagalakshmi Vedula, Sudheer Kumar Kandukuri, Srinivasa Rao Gundumolu. Development and Validation of RP-HPLC Method for the Estimation of L-Methyl Folate and Tofisopam in combined Formulation. Asian J. Research Chem. 2021; 14(1):28-36. doi: 10.5958/0974-4150.2021.00005.5


REFER ENCES:
1.    Kelly CB, Mc Donnell, AP, Johnston TG, Mulholland C, Stephen JC, Dorothy Mc, Alun E, Alexdander SW.  The MTHFR C677T polymorphism is associated with depressive episodes in patients from Northern Ireland. Journal of Psyc., 2004; 18(4): 567- 571.
2.    Gilbody S, Lewis S, Lightfoot T. Methylenetetrahydrofolate reductase (MTHFR) genetic polymorphisms and psychiatric disorders: a HuGE review.  Am. J. Epidemiol., 2007; 165(1): 1- 13.
3.    Pietrzik K, Lynn B, Barry S. Folic acid and L-5-methyltetrahydrofolate: comparison of clinical pharmacokinetics and pharmacodynamics. Clinical Pharmacokinetics, 2010; 49(8):535-548.
4.    L-MethylFolate monograph (Online) available on URL: https://www.drugbank.ca/drugs/DB04789
5.    Skoog DA, Holler FJ, Nieman TA. Principles of Instrumental Analysis.5th ed. Newyork: Thomson Brooks/Cole; 1998; 329-35.
6.    Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental Methods Analysis.7th ed. New Delhi: CBS Publishers and Distributors; 1999; 1-12.
7.    Sharma BK. Instrumental methods of chemical Analysis. 19th ed. Meerut: Geol Publishing house; 2003; 5-11.
8.    Niraj V, Sangita P. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Nebivolol and Indapamide in Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2014; 4(3): 98-102.
9.    Govindarao K, Sowjanya V, Haripriya M. Method Development and Validation for Simultaneous Estimation of Omeprazole and Domperidone by RP-HPLC. Asian J. Pharm. Ana. 2015; 5(4): 195-205.
10.    Kumaraswamy G, Lalitha R, Sadhana B, Suthakaran R, Pallavi K. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Albendazole and Praziqantel in Tablet Dosage Form. Asian J. Pharm. Ana. 2015; 5(3): 115-118.
11.    Janaki Pathi P, Appala Raju N. The Estimation of Epalrestat in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; 2(2): 49-51.
12.    Renu S, Badri Prakash N, Mahendra Kumar N, Joytosh B. Development and Validation of Simultaneous Estimation Method for Amoxycillin Trihydrate and Tinidazole in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2013; 3(2): 66-71.
13.    Kumaraswamy G, Ravindra N, Jyothsna B. Development and Validation of a Reversed-Phase HPLC Method for Simultaneous Determination of Aspirin, Atenolol and Amlodipine in Capsules Dosage Forms. Asian J. Pharm. Ana. 2014; 4(3): 116-120.
14.    Akhilesh G, Swati R, Arun P. Method Development and Photolytic Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(2): 29-33.
15.    Vijaya Sri K, Anusha M, Ravinder Reddy S. A Rapid RP-HPLC Method development and Validation for the Analysis of Linagliptinin Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2015; 5(1): 16-20.
16.    Swapna J, Madhu CH, Srivani M, Sumalatha M, Nehalatha Y, Anusha Y. Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; 2(3): 85-89.
17.    Thangabalan B, Avinash L, Chaitanya G, Sunitha N, Manohar Babu S. Stability Indicating RP–HPLC Method for the Estimation of Acamprosate in Pure and Tablet Dosage Form. Asian J. Pharm. Ana. 2013; 3(4): 141-146.



Recomonded Articles:

Author(s): Bulusu Lakshmi Sushma1, Gutta Madhusudhan, Anireddy Jayashree

DOI: 10.5958/0974-4150.2017.00014.1         Access: Open Access Read More

Author(s): Y. Padmavathi, Akari Anjali, Nayaka Raghavendra Babu, P Ravi Kumar

DOI: 10.5958/0974-4150.2017.00064.5         Access: Open Access Read More

Author(s): Vatchavai Bhaskara Raju, Bonthu Mohan Gandhi, Kamatham Srinivas Sumanth, Kolli Srinivas, Tupakula N Venkata Lakshmi Neeraja

DOI: 10.5958/0974-4150.2017.00030.X         Access: Open Access Read More

Author(s): SS Chitlange, Kiran Bagri, DM Sakarkar

DOI:         Access: Open Access Read More

Author(s): Mukund Nagarnaik, Arun Sarjoshi, Ajay Bodkhe, Bhupendra Khanal, Mayuri Pise, Girish Pandya

DOI: 10.5958/0974-4150.2015.00102.9         Access: Open Access Read More

Author(s): B. Balaswami, P. Venkata Ramana, B. Subba Rao, P. Sanjeeva

DOI: 10.5958/0974-4150.2018.00023.8         Access: Open Access Read More

Author(s): Ismail, R Rajavel, M Ganesh, M Jagadeeswaran, K Srinivasan, J Valarmathi, T Sivakumar

DOI:         Access: Open Access Read More

Author(s): Tentu Nageswara Rao, Muralidhar Reddy Avuthu, B. Venkata Reddy, SNVS Murthy

DOI: 10.5958/0974-4150.2016.00076.6         Access: Open Access Read More

Author(s): PA Jadhav, CS Raut, JP Bidada, BB Buwa, PN Dhabale, SC Dhawale

DOI:         Access: Open Access Read More

Author(s): Prasanna Reddy Battu, MS Reddy

DOI:         Access: Open Access Read More

Author(s): Sravani A

DOI: 10.5958/0974-4150.2018.00144.X         Access: Open Access Read More

Author(s): VB Kshirsagar, UA Deokate, VB Bharkad, SS Khadabadi

DOI:         Access: Open Access Read More

Author(s): J Vanitha, A Saravana Kumar, M Ganesh, VS Saravanan

DOI:         Access: Open Access Read More

Author(s): RB Kakde, VH Kotak, DL Kale

DOI:         Access: Open Access Read More

Asian Journal of Research in Chemistry (AJRC) is an international, peer-reviewed journal devoted to pure and applied chemistry..... Read more >>>

RNI: Not Available                     
DOI: 10.5958/0974-4150 

Popular Articles


Recent Articles




Tags