Author(s): Bhuvnesh Kumar Singh, Harishchandra Verma, Nikhil Singh, Pradeep Singh, Amit Chaudhary, Ashok Kumar Rajpoot

Email(s): bhuvneshiftm@gmail.com

DOI: 10.52711/0974-360X.2024.00293   

Address: Bhuvnesh Kumar Singh1*, Harishchandra Verma1, Nikhil Singh1, Pradeep Singh2, Amit Chaudhary3, Ashok Kumar Rajpoot1
1Moradabad Educational Trust, Group of Institutions, Faculty of Pharmacy, Moradabad, Uttar Pradesh, India.
2Department of Pharmacy, College of Health Sciences Debre Tabor University Ethiopia.
3Chitkara University School of Pharmacy, Chitkara University, Himachal Pradesh 174103, India.
*Corresponding Author

Published In:   Volume - 17,      Issue - 4,     Year - 2024


ABSTRACT:
In this work, a novel method for the simultaneous estimate of Montelukast (MONT) and Ebastine (EBAS) in bulk drugs was developed using Central Composite Design (CCD).A novel reverse-phase high-performance liquid chromatography (RP-HPLC) approach for the simultaneous measurement of Montelukast and Ebastine in bulk and formulation is what this work aims to create and test.A novel reverse-phase high-performance liquid chromatography (RP-HPLC) approach for the simultaneous measurement of Montelukast and Ebastine in bulk and formulation is what this work aims to create and test.With isocratic elution at a flow rate of 0.8 ml min-1 and a diode array detector operating at 241 nm, the separation was accomplished using methanol and 0.02M ammonium acetate buffer (pH 5.5 adjusted with diluted acetic acid) in the ratio of 80:20 v/v. Methanol composition (percent) (A), pH (B), and flow rate (C) were three independent variables that were examined.This method showed good linearity over a range of 2.5–25 µg/ml for both drugs. MONT limit of detection (LOD) and limit of quantitation (LOQ) were 0.298 and 0.905µg/ml while LOD and LOQ for EBAS were 0.594 and 1.80For both drugs, this technique demonstrated high linearity throughout a range of 2.5–25 µg/ml. Limits of detection (LOD) and quantitation (LOQ) for MONT were 0.298 and 0.905 µg/ml and 0.594 and 1.80 µg/ml for EBAS, respectively.The statistical data analysis determined that the Methanol composition and pH were the two independent variables that were most significant, with P 0.001. The suggested technique worked well and was optimised for the CCD model-based simultaneous estimate of both drugs.


Cite this article:
Bhuvnesh Kumar Singh, Harishchandra Verma, Nikhil Singh, Pradeep Singh, Amit Chaudhary, Ashok Kumar Rajpoot. Optimization of HPLC Method by Using Central Composite Design for Simultaneous Estimation of Montelukast and Ebastine Dosage Form. Research Journal of Pharmacy and Technology.2024; 17(4):1884-0. doi: 10.52711/0974-360X.2024.00293

Cite(Electronic):
Bhuvnesh Kumar Singh, Harishchandra Verma, Nikhil Singh, Pradeep Singh, Amit Chaudhary, Ashok Kumar Rajpoot. Optimization of HPLC Method by Using Central Composite Design for Simultaneous Estimation of Montelukast and Ebastine Dosage Form. Research Journal of Pharmacy and Technology.2024; 17(4):1884-0. doi: 10.52711/0974-360X.2024.00293   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2024-17-4-67


REFERENCES:
1.    Muijsers RB, Noble S. Montelukast. Pediatric Drugs. 2002; 4(2): 123-39.
2.    Nayak A, Langdon RB. Montelukast in the treatment of allergic rhinitis. Drugs. 2007; 67(6): 887-901.doi: 10.2165/00003495-200767060-00005
3.    Kittana N, Hattab S, Ziyadeh-Isleem A, Jaradat N, Zaid AN. Montelukast, current indications and prospective future applications. Expert Review of Res Medi. 2016; 10(9): 943-56. doi: 10.1080/17476348.2016.1207533
4.    Hurst M, Spencer CM. Ebastine: an update of its use in allergic disorders. Drugs. 2000 Apr; 59(4): 981-1006. doi: 10.2165/00003495-200059040-00018. PMID: 10804044.
5.    Van Cauwenberge P, De Belder T, Sys L. A review of the second-generation antihistamine ebastine for the treatment of allergic disorders. Expert OpinPharmacother. 2004 Aug; 5(8): 1807-13. doi: 10.1517/14656566.5.8.1807. PMID: 15264995.
6.    Sastre J. Ebastine in allergic rhinitis and chronic idiopathic urticaria. Allergy. 2008 Dec; 63 Suppl 89: 1-20. doi: 10.1111/j.1398-9995.2008.01897.x. PMID: 19032340.
7.    Mahmoud M. Sebaiy, Abdullah A. El-Shanawany, Sobhy M. El-Adl, Lobna M. Abdel-Aziz, Hisham A. Hashem. Rapid RP-HPLC Method for Simultaneous Estimation of Norfloxacin and Tinidazole in Tablet Dosage Form. Asian J. Pharm. Ana. 2011; 1(4): 79-84.
8.    Satyanarayana L, Naidu SV, Rao MN, Ayyanna C, Kumar A. The Estimation of Raltigravir in Tablet dosage form by RP-HPLC. Asian J. Pharm. Ana. 2011; 1(3): 56-58.  
9.    Furlanetto S, Orlandini S, Mura P, Sergent M, Pinzauti S. How experimental design can improve the validation process. Studies in pharmaceutical analysis. Anal Bioanal Chem. 2003 Nov; 377(5): 937-44. doi: 10.1007/s00216-003-2189-2. Epub 2003 Sep 16. PMID: 13680061.
10.    Buralla KK, Parthasarathy V. Central Composite Design based Development and Validation of an RP-HPLC Method for Paclitaxel in Bulk and Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2020; 13(10): 4895-4902.
11.    Kumar A, Verma R, Pal K, Purohit D, Pandey P,  Mittal V, Kaushik D. Quality by design approach for developing Emulgel of Diclofenac with central composite Design and Evaluation using in vitro release testing. Research Journal of Pharmacy and Technology. 2022; 15(7): 3260-6.
12.    Saranya R, Tamilarasan K, Peatciyammal N, Sai RL, Kumar MD. Statistical Optimization of Lipase Production from Bacillus spp by Central Composite Design. Research J. Engineering and Tech. 2011: 2(1): 31-35.
13.    Dhumal DM, Ganorkar SB, Patil MU, Singh D, Sharma MC, Bhadoriya KS. RP-HPLC-PDA Analyses of Tapentadol: Application of Experimental Design. J Ana Chem Lett. 2016: 214-223. doi.org/10.1080/22297928.2015.1068705
14.    Ebrahimi-Najafabadi H, Leardi R, Jalali-Heravi M. Experimental design in analytical chemistry--part I: theory. J AOAC Int. 2014 Jan-Feb; 97(1):3-11. doi: 10.5740/jaoacint.sgeebrahimi1. PMID: 24672854.
15.    Torbeck LD, Branning RC. The role of designed experiments. In: Torbeck LD, ed. Pharmaceutical and medical device validation by experimental design, New York: Informa Healthcare; 2007: 98.doi.org/10.3109/9781420055702
16.    Karakucuk A, Celebi N, Teksin ZS. Preparation of ritonavir nanosuspensions by microfluidization using polymeric stabilizers: I. A Design of Experiment approach. Eur J Pharm Sci. 2016 Dec 1; 95: 111-121. doi: 10.1016/j.ejps.2016.05.010. Epub 2016 May 13. PMID: 27181836.
17.    Uğurlu T, Karaçiçek U, Rayaman E. Optimization and evaluation of clarithromycin floating tablets using experimental mixture design. Acta Pol Pharm. 2014 Mar-Apr; 71(2): 311-21. PMID: 25272652.
18.    SarısaltıkYaşın D, ArslantürkBingül A, Karaküçük A, Teksin ZŞ. Development and Validation of an HPLC Method Using an Experimental Design for Analysis of Amlodipine Besylate and Enalapril Maleate in a Fixed-dose Combination. Turk J Pharm Sci. 2021 Jun 18; 18(3): 306-318. doi: 10.4274/tjps.galenos.2020.89725. PMID: 34157820; PMCID: PMC8231320.
19.    Borman P, Elder D. Q2 (R1) validation of analytical procedures. ICH Quality guidelines. 2017; 5:127-66. doi.org/10.1002/9781118971147.ch5
20.    Walfish S. Analytical methods: a statistical perspective on the ICH Q2A and Q2B guidelines for validation of analytical methods. BioPharm International. 2006;19(12): 1-6.
21.    Branch SK. Guidelines from the International Conference on Harmonisation (ICH). J Pharm Biomed Anal. 2005 Aug 10; 38(5): 798-805. doi: 10.1016/j.jpba.2005.02.037. PMID: 16076542.
22.    Chaudhary A, Singh BK. Method Development and Validation for simultaneous Quantification of Remogliflozin and Metformin in Bulk and Tablets by RP-HPLC. Research J. Pharm. and Tech 2022; 15(10): 4709-4. doi: 10.52711/0974-360X.2022.00791
23.    Chaudhary A, Singh BK. Simultaneous Estimation of Pregabalin and Etoricoxib using Novel HPLC Method: An Application in Quantitative Analysis of Pharmaceutical Dosage Forms. Indian J. Pharm. Educ. Res.. 2021; 55(3): S837-43. doi: 10.5530/ijper.55.3s.191.
24.    Ghosh S, Bomma S, Prasanna VL, Vidyadhar S, Banji D, Roy S. Method development and validation of Rilpivirine in bulk and Tablet doses form by RP-HPLC method. Research J. Pharm. and Tech. 2013; 6(3): 240-243.
25.    Agrahari V, Bajpai M, Nanda S. Essential Concepts of Mobile Phase Selection for Reversed Phase HPLC. Research J. Pharm. and Tech. 2013; 6(5): 459-464.

Recomonded Articles:

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 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available