Author(s): K. Swapna, K. Deepthi, T. Padmini

Email(s): paddu2505@gmail.com

DOI: 10.5958/0974-360X.2021.00165.7   

Address: Dr. K. Swapna1, Dr. K. Deepthi2, T. Padmini3*
1Sphoorthy Engineering College, Nadergul, Sagar Road, Saroornagr, R. R. (Dist) Telangana State, 501510.
2Mahaveer Institute of Science and Technology, Vyasapuri, Bandlaguda, Hyderabad.
3Assistant Professor, Megha Institute of Engineering and Technology for Women. Edulabad, Ghatkesar, Hyderabad.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2021


ABSTRACT:
An accurate, sensitive, precise, rapid and isocratic RP-HPLC method for simultaneous estimation of Cilastatin, Imipenem and Relebactum in the bulk drug and in pharmaceutical metered dose inhalers is developed and validated. The best separation achieved on Hypersil BDS Reverse Phase-C18 column (250mm × 4.6 x 5-µm) with acetonitrile as the organic modifier and dipotassium hydrogen phosphate [0.03M] in water with pH 3.2 adjusted with ortho-phosphoric acid (0.1% v/v) as mobile phase at a flow rate of 1.0mL min-1. UV detection carried out at 265nm. Retention times observed at 3.107 min. for Imipenem, 3.885 min. for Cilastatin and 10.516 min for Relebactum. A linear response observed at concentration range of 20-120 mcg/ml for Cilastatin, 20-120mcg/ml for Imipenem and 10-60 mcg/ml for Relebactum respectively with average correlation coefficient of = 0.999. The percentage assay for Cilastatin, Imipenem and Relebactum were found 98.37, 99.72 and 99.18% respectively. The limit of detection (LOD) was found to be 0.01µg/mL for Cilastatin, 0.02µg/mL for Imipenem and 0.05µg/mL for Relebactum. The limit of Quantification found to be 0.03µg/mL, 0.06µg/mL and 0.15µg/mL for Cilastatin, Imipenem and Relebactum respectively. The excipients present in the formulation did not interfere with the assay procedure. The method is suitable for application in quality-control laboratories, because it is simple and rapid with good accuracy and precision.


Cite this article:
K. Swapna, K. Deepthi, T. Padmini. A RP-HPLC Method development and Validation for Simultaneous Estimation of Imipenem, Cilastatin and Relebactum in API and in Pharmaceutical Lyophilized powder for injection. Research J. Pharm. and Tech. 2021; 14(2):925-930. doi: 10.5958/0974-360X.2021.00165.7


REFERENCE:
1.    Imipenem spectrum of bacterial susceptibility and Resistance", Retrieved 4 May 2012.
2.    Köller M, Brom J, Raulf M, König W. Cilastatin (MK 0791) is a potent and specific inhibitor of the renal leukotriene D4-dipeptidase. Biochem Biophys Res Commun, 1985; 131(2): 974-79.
3.    Rizk ML, Rhee EG, Jumes PA, Gotfried MH, Zhao T, Mangin E, Bi S, Chavez-Eng CM, Zhang Z, Butterton JR: Antimicrob Agents Chemother. 2018 Feb 23;62(3)
4.    Forsyth RJ, Ip DP. J Pharm Biomed Anal, 1994; 12(10): 1243-48.
5.    Parra A, Garcia-Villanova J, Ródenas V, Gómez MD. First- and second-derivative spectrophotometric determination of imipenem and cilastatin in injections. J Pharm Biomed Anal, 1993; 11(6): 477-82.
6.    Baldha RG, Vandana BP, Mayank B. Int J Pharm Tech Res., 2010; 2(2): 1563–68.
7.    Omar ST, Itab S. J Taibah Univ Med Sci., 2014; 9(3): 178-81.
8.    Sandhya Rani N, Supraja K, Priyanka Sharmila Ch, Vamshikrishna G, Sreekanth G. Inventi Rapid: Pharm Anal Qua Assu, 2015; 2015(3): 1-9
9.    Srinivasan R, Mary KL, Kumar DR, Chandana P. Pharmanest: Int J Adv Phar Sci., 2014; 5(5): 2400-04.
10.    Natalija N, Rumenka P, Jelena A, Aneta D. J Liq Chromatogr Relat Technol, 2014; 37(4): 447-60.
11.    Zhe-Yi H, Bradley AB, Laizure SC, Vanessa LH, Robert BP, William LH. J Mass Spectrom, 2013; 48(8): 945–50.
12.    Xuf Y, Xie W, Miller-Stein CM, Woolf EJ. Rapid Commun Mass Spectrom, 2009; 23(14): 2195–2205.
13.    ICH Stability Testing of New Drug Substances and Products, Q1A (R2), ICH, 2003.
14.    ICH Validation of Analytical Procedures; Text and Methodology; Q2 (R1), ICH, 2005.

Recomonded Articles:

Author(s): Ravindranath S. Misal, Vishawas R. Potphode, Vijay R. Mahajan

DOI: 10.5958/0974-360X.2017.00218.9         Access: Open Access Read More

Author(s): Niharika, Navneet Verma

DOI: 10.5958/0974-360X.2016.00182.7         Access: Open Access Read More

Author(s): A. S. K. Sankar, B. Datchayani, N. Balakumaran, Mohammed Rilwan, R. Subaranjani

DOI: 10.5958/0974-360X.2017.00047.6         Access: Open Access Read More

Author(s): U.S Mahadeva Rao, Khamsah Suryati Mohd, Abdurrazaq Muhammad, Bashir Ado Ahmad, Mohaslinda Mohamad, Rosmawati Mat Ali

DOI: Not Available         Access: Open Access Read More

Author(s): Khan MU, Ghafoor A, Ishaq MT, Hasan B, Salman A, Tengku MA, Zubaidi AL, Nodrin S, Atif AB, Ilyas MN

DOI: 10.5958/0974-360X.2018.00794.1         Access: Open Access Read More

Author(s): Peethala Prathyusha, Raja Sundararajan, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati

DOI: 10.5958/0974-360X.2020.00507.7         Access: Closed Access Read More

Author(s): Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya

DOI:         Access: Open Access Read More

Author(s): Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita M. Charde

DOI: Not Available         Access: Open Access Read More

Author(s): Archana Kushwaha, Jayanti Jaiswal, Priya Singh, Neha Rathore, Jai Prakash Dhruw, Ishu Sahu, Chhaya Singh, Krinsha Kumar Sahu, Mukta Agrawal, D. K. Tripathi, Ajazuddin, Amit Alexander

DOI: 10.5958/0974-360X.2017.00270.0         Access: Open Access Read More

Author(s): Mukta D. Naykode, Durgacharan A. Bhagwat, Swapnil D. Jadhav, Harinath N. More

DOI: 10.5958/0974-360X.2017.00133.0         Access: Open Access Read More

Author(s): Suha Alnaeb, Youssef Alahmad, Saleh Trefi

DOI: 10.5958/0974-360X.2019.01035.7         Access: Open Access Read More

Author(s): Bahubali N. Patil, Vamshi Krishna Tippavajhala, Girish Pai K

DOI: 10.5958/0974-360X.2019.00140.9         Access: Open Access Read More

Author(s): Vijayalakshmi. S , Disalva. X, Chittaranjan Srivastava, Arun A

DOI: 10.5958/0974-360X.2019.00520.1         Access: Open Access Read More

Author(s): R Deveswaran, S Bharath, BV Basavaraj, Sindhu Abraham, Sharon Furtado, V Madhavan

DOI:         Access: Open Access Read More

Author(s): Homendra Kumar Sahu, Kamdev Sen, Raju Patel, Hulash Sahu, Deepika Sahu, Gulshan Sahu, Chandrashekhar Jain, Narayan Prasad Chandra, Mukta Agrawal, D. K. Tripathi, Ajazuddin, Amit Alexander

DOI: 10.5958/0974-360X.2017.00173.1         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags