MENU

Author(s): Sufiyan Ahmad, Nikhil Sonawane, A. U. Tatiya

Email(s): sufimpharm@rediffmail.com

DOI: 10.52711/0974-360X.2022.00967   

Address: Sufiyan Ahmad*, Nikhil Sonawane, A. U. Tatiya
Department of Quality Assurance, Gangamai College of Pharmacy, Nagaon, Dist. Dhule (M.S.), India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 12,     Year - 2022


ABSTRACT:
An accurate, precise and reproducible RP-HPLC method was developed for the simultaneous quantitative determination of Azelnidipine and Telmisartan in tablet dosage forms. Agilent (S.K) Gradient System UV Detector and C18 column with 250mm x 4.6mm i.d and 5µm particle size Acetonitrile: ph Buffer (80:20v/v) pH 3 was used as the mobile phase for the method. The detection wavelength was 237nm and flow rate was 0.9 ml/min. In the developed method, the retention time of Azelnidipine and Telmisartan were found to be 4.77 min and 11.97min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. The developed method was validated according to the ICH guidelines. In this methods linearity, precision, range, robustness were observed. The method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis of AZN and TMZ in bulk drug as well as in formulations.


Cite this article:
Sufiyan Ahmad, Nikhil Sonawane, A. U. Tatiya. Analytical Method Development and Validation for the Simultaneous Estimation of Azelnidipine and Telmisartan by RP-HPLC in Bulk and Tablet Dosage Forms. Research Journal of Pharmacy and Technology 2022; 15(12):5736-0. doi: 10.52711/0974-360X.2022.00967

Cite(Electronic):
Sufiyan Ahmad, Nikhil Sonawane, A. U. Tatiya. Analytical Method Development and Validation for the Simultaneous Estimation of Azelnidipine and Telmisartan by RP-HPLC in Bulk and Tablet Dosage Forms. Research Journal of Pharmacy and Technology 2022; 15(12):5736-0. doi: 10.52711/0974-360X.2022.00967   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-12-61


REFERENCE:
1.    Walker R and Whittlesea C. Clinical Pharmacy and Therapeutics; 5 th Edn; Elsevier, 2007; 295-307.
2.    Tamargo J and Ruilope LM., Investigational calcium channel blockers for the treatment of hypertension, Expert Opinion on Investigational Drug, 2016; 1-51.
3.    Goodman and Gilman’s The pharmacological basis of therapeutics; 10th Edn; Medical Publishing Division, 2001; 1804.
4.    Shewale VU et al., Azelnidipine: A Review on Therapeutic Role in Hypertension. Journal of Drug Delivery and Therapeutics, 2019; 9: 1002-1005. doi.org/10.22270/jddt.v9i3-s.3090.
5.    Chen B, Yin Zhuang Zhang, Jian Quan Luo. Wei Zhang. Clinical use of Azelnidipine in the treatment of hypertension in Chinese patients. Therapeutics and Clinical Risk Management, 2015; 11: 309-318. doi: 10.2147/TCRM.S64288.
6.    The Indian Pharmacopoeia, Government of India, Ministry of Health and Family welfare; 7th ed., The Indian Pharmacopeia Commission, Ghaziabad, 2018; II: 1304-1305, 3319-3320.
7.    Japanese Pharmacopoeia, 17th Edition, The Ministry of Health Labour and Welfare, 2016; 704-707.
8.    Nirma Chavda, Suresh Kumar. A Review article on Analytical Method Development for the combination of Azelnidipine and Telmisartan. Asian J. of Pharmaceutical Analysis, 2021; 11(3): 227-4. doi: 10.52711/2231-5675.2021.00040.
9.    ICH Harmonised Tripartite Guidelines. Validation of Analytical Procedures: Text and Methodology Q2 (R1). International conference on Harmonization, Geneva, Switzerland, 2005; 1-13.
10.    Taduvai Venkata Raveendranath, Rajaiah Thangaraj Saravanakumar, Stability indicating UPLC method devepoment and validation for simultaneous determination of Encorafenib and Binimetinib in Formulation, International Journal of Pharmaceutical Sciences and Drug Research 2020;12(5):488-494. DOI:10.25004/IJPSDR.2020.120509.
11.    ICH, 2003. ICH Q1 A (R2) Stability Testing of New Drug Substances and Products. International Conference on Harmonization, Geneva.
12.    ICH, 2005. Technical requirements for the registration of pharmaceutical for human use; validation of analytical procedures: Text and Methodology Q2(R1); IFPMA: Geneva, Switzerland, November, 2005, pp. 1–13.
13.    Dibya Das, Dhiman Halder, Himangshu Sekhar Maji, Pintu Kumar De, Tapan Kumar Pal. Special Emphasis on Bioanalytical Method Development and Validation of an Anti-Hypertensive Drug Azelnidipine by LC-ESI-MS/MS in Healthy Human Volunteer’s Blood Plasma. Research Journal of Pharmacy and Technology. 2021; 14(7):3571-7. doi: 10.52711/0974-360X.2021.00618.
14.    Kalyani Lingamaneni, Mukthinuthalapati Mathrusri Annapurna. Development and validation of a new stability indicating liquid chromatographic method for the simultaneous quantification of Hydrochlorthiazide and Telmisartan. Research J. Pharm. and Tech. 2021; 14(4):2081-8. doi: 10.52711/0974-360X.2021.00369
15.    Sheetal, Sonia, Lakshmi K K S. Validation of Telmisartan by UV Spectrophotometry Method. Research J. Pharm. and Tech. 2019; 12(5):2413-2415.
16.    Aruna P, Gayathiri NM. Cardioprotective Activity of Telmisartan, Metformin and its combination against Doxorubicin induced myocardial infarction in rat model. Research J. Pharm. and Tech. 2018; 11(12): 5293-5296. doi : 10.5958/0974-360X.2018.00964.2
17.    Sonia K, Nappinnai M, Panneerselvam P. Stability indicating method development and validation of Telmisartan and Ramipril by UV spectrophotometry. Research J. Pharm. and Tech 2018; 11(7): 3087-3090. doi: 10.5958/0974-360X.2018.00567.X  
18.    Aishwarya P, Joglekar. Method Development and validation for the estimation of Telmisartan and Chlorthalidone in bulk and pharmaceutical dosage form by HPTLC method. Research J. Pharm. and Tech. 2015; 8(4): 376-381. doi: 10.5958/0974-360X.2015.00063.3
19.    Jane J, Mani Prasad. Simultaneous estimation of Metoprolol and Telmisartan dosage form. Research J. Pharm. and Tech. 2014; 7(9): 1020-1024.  
20.    Rutuja M Sanap, Sarika R. Wavhale, Vaibhavi V. Kunjir, Rajkumar V. Shete. Analytical Method Development and Validation for Telmisartan, Chlorthalidone and Amlodipine by UV- Spectroscopic Method. Research Journal of Pharmacy and Technology. 2021; 14(11):6049-4. doi: 10.52711/0974-360X.2021.01051
21.    Susmitha A Sai, Kokilambigai K S, Lakshmi K S. Spectrophotometric Quantification of Telmisartan Employing Multivariate Calibration Technique in Bulk and Pharmaceutical Formulations. Research J. Pharm. and Tech. 2019; 12(4):1799-1805. doi: 10.5958/0974-360X.2019.00300.7
22.    Hamid Khan, Mushir Ali, Alka Ahuja, Javed Ali, Sayeed Ahmad. Application of Validated HPTLC Method for Dissolution Study of FDC Tablets Containing Telmisartan and Hydrochlorothiazide. Research J. Pharm. and Tech. 2017; 10(4): 1149-1154. doi: 10.5958/0974-360X.2017.00207.4
23.    Kalyani Lingamaneni, Mukthinuthalapati Mathrusri Annapurna. Development and Validation of a New Stability Indicating Liquid Chromatographic Method for the Simultaneous quantification of Hydrochlorthiazide and Telmisartan. Research Journal of Pharmacy and Technology. 2021; 14(4):2081-8. doi: 10.52711/0974-360X.2021.00369

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

Journal Policies & Information


Recent Articles




Tags


Not Available