Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Method Development and Validation of Simultaneous Estimation of Atenolol, Amlodipine besylate and Aspirin in bulk drug and formulation by HPTLC


Affiliations
1 Department of Pharmaceutical Chemistry, Sinhgad Technical Education Society’s, Smt. Kashibai Navale College of Pharmacy, Kondhwa, Pune, Maharashtra,, India
2 Pro Vice Chancellor, Amity University U.P. Lucknow Campus, Lucknow, Uttar Pradesh,, India
     

   Subscribe/Renew Journal


A unique, easy, accurate and precise HPTLC method is demonstrated for simultaneously estimating Atenolol, Amlodipine besylate and Aspirin in bulk drug (API) and in capsule dosage forms. The three drugs were separated using precoated aluminum plates, silica gel 60 F254 was used for coating the plates. The mobile phase used for separating the three drugs was n-butanol, water and acetic acid in the ratio of 8: 2: 0.2 v/v/v. The separated bands were evaluated at 235 nm. RF values for the three drugs were 0.23 ± 0.02, 0.47 ± 0.02 and 0.70 ± 0.02 for Atenolol, Amlodipine besylate and Aspirin, respectively. All the three drugs were very well resolved from each other depicting resolution of more than 2. Linearity was performed in the concentration range of 100-600 ng/spot for Atenolol, Amlodipine besylate and Aspirin, and a good linear curve was displayed over the concentration vs area plot. The limit of detection (LOD) was 80 ng/spot and limit of quantitation (LOQ) was 100 ng/spot for Atenolol, Amlodipine besylate and Aspirin, respectively. HPTLC method was successfully applied to capsule dosage form and no interference from excipients was observed. The developed method was validated as per ICH guideline and was found to be specific, precise, robust and accurate. Hence this method can be useful for routine analysis of Atenolol, Amlodipine besylate and Aspirin in pure drug and capsule forms.

Keywords

Amlodipine besylate, Aspirin, Atenolol, Densitometry, High performance thin layer chromatography and Validation.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Drug bank, [Online], Available: https://www.drugbank.ca/drugs/DB00335 [Accessed: 28 June 2020].

  • Drug bank, [Online], Available: https://www.drugbank.ca/drugs/DB00381 [Accessed: 28 June 2020].

  • Drug bank, [Online], Available: https://www.drugbank.ca/drugs/DB00945 [Accessed: 28 June 2020].

  • Kasture AV, Ramteke M. Simultaneous UV-spectrophotometric method for the estimation of Atenolol and Amlodipine besylate in combined dosage form. Indian Journal of Pharmaceutical Sciences. 2006; 68(3):394-396.

  • Golcu A. New, simple, and validated UV-spectrophotometric method for the estimation of some beta blockers in bulk and formulations. Journal of Analytical Chemistry. 2008; 63:538-543.

  • Sawant RL, Kale RB, Amol S Ghodechor, Sherkar AB, Sanklecha KR. Development and validation of UV spectrophotometric methods for simultaneous estimation of Amlodipine besylate and Theophylline. Asian Journal of Pharmaceutical Analysis. 2017; 7(3):159-162.

  • Patil PA, Raj HA, Sonara GB. Simultaneous estimation of Atenolol and Ivabradine HCl using UV-Spectrophotometry. Asian Journal of Pharmaceutical Analysis. 2016; 6(2):109-114.

  • Chaudhari SS, Phalak SD. Simultaneous equation method for Aspirin and Omeprazole (Yosprala) tablet by using UV-Spectroscopy. Asian Journal of Research in Pharmaceutical Sciences. 2020; 10(2):69-72.

  • Khaleel M, Havannavar NT, Som S, Banu VTS. Development of a new, simple, sensitive and cost-effective method for estimation of Atenolol in formulation and bulk. Research Journal of Pharmaceutical Dosage Forms and Tech. 2010; 2(1):72-76.

  • Mandale TR, Kondawar MS, Kadam SD. Development and validation of analytical method for simultaneous estimation of Amlodipine Besylate and Celecoxib in pure and combined dosage form. Research Journal of Pharmacy and Technology. 2020; 13(9):4280-4284.

  • Argekar AP, Powar SG. Simultaneous determination of Atenolol and Amlodipine in tablets by high-performance thin-layer chromatography. Journal of Pharmaceutical and Biomedical Analysis. 2000; 21(6):1137-1142.

  • Deore PV, Shirkhedkar AA, Surana SJ. Simultaneous TLC-densitometric analysis of Atenolol and Lercanidipine hydrochloride in tablets. Acta Chromatographica. 2008; 20(3):463-473.

  • Sharma A, Tailang M, Khare S, Shukla T. RP-HPLC determination of Atenolol in its pharmaceutical dosage forms. Asian Journal of Pharmaceutical Analysis. 2009; 2(4):485-487.

  • Sharma A, Tailang M, Gupta B, Acharya A. RP HPLC determination of Amlodipine in its pharmaceutical dosage forms. Asian Journal of Pharmaceutical Analysis. 2010; 3(1):129-131.

  • Mahesh HRK, Babu KS. A novel stability indicating HPLC assay method for simultaneous estimation of Clopidogrel and Aspirin in tablet dosage form by using core shell technology column. Research Journal of Pharmacy and Technology. 2015; 8(2): 172-176.

  • Bhusari VK, Dhaneshwar SR. Validated HPTLC method for simultaneous estimation of Atenolol and Aspirin in bulk drug and formulation. International scholar research library. 2012; 1-5.

  • Bhadoriya AS, Padekar SS, Patil VD, Shinde SN, Choudhari VP, Kuchekar BS. Development and validation of ratio spectra derivative spectrophotometric method for determination of ternary mixture of Aspirin, Atenolol and Amlodipine Besylate in formulation. Asian Journal of Research in Chemistry. 2010; 3(3):562-565.

  • Bhusari VK, Dhaneshwar SR. Validated HPLC method for simultaneous quantitation of Amlodipine Besylate, Atenolol and Aspirin in bulk drug and formulation. Journal of Pharmaceutical and Biomedical Sciences. 2012; 17(9):1-6.

  • 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 Journal of Pharmaceutical Analysis. 2014; 4(3):116-120.

  • Kumaraswamy G, Lalitha G, Ravindra N, Pradeesha KB. Simultaneous estimation of Amlodipine, Atenolol and Hydrochlorothiazide in bulk and tablet dosage form by RP-HPLC method. Asian Journal of Pharmaceutical Analysis. 2014; 4(4):131-136.

  • Sinha PK, Damle MC, Bothra KG. A validated stability indicating HPTLC method for determination of Aspirin and Clopidogrel Bisulphate in combined dosage form. Eurasian Journal of Analytical Chemistry. 2009; 4(2):152-160.

  • Q2(R1), Validation of analytical procedures: text and methodology, International Conference on Harmonization (ICH), Geneva. 2005.


Abstract Views: 99

PDF Views: 0




  • Method Development and Validation of Simultaneous Estimation of Atenolol, Amlodipine besylate and Aspirin in bulk drug and formulation by HPTLC

Abstract Views: 99  |  PDF Views: 0

Authors

Vidhya K. Bhusari
Department of Pharmaceutical Chemistry, Sinhgad Technical Education Society’s, Smt. Kashibai Navale College of Pharmacy, Kondhwa, Pune, Maharashtra,, India
Sunil R. Dhaneshwar
Pro Vice Chancellor, Amity University U.P. Lucknow Campus, Lucknow, Uttar Pradesh,, India

Abstract


A unique, easy, accurate and precise HPTLC method is demonstrated for simultaneously estimating Atenolol, Amlodipine besylate and Aspirin in bulk drug (API) and in capsule dosage forms. The three drugs were separated using precoated aluminum plates, silica gel 60 F254 was used for coating the plates. The mobile phase used for separating the three drugs was n-butanol, water and acetic acid in the ratio of 8: 2: 0.2 v/v/v. The separated bands were evaluated at 235 nm. RF values for the three drugs were 0.23 ± 0.02, 0.47 ± 0.02 and 0.70 ± 0.02 for Atenolol, Amlodipine besylate and Aspirin, respectively. All the three drugs were very well resolved from each other depicting resolution of more than 2. Linearity was performed in the concentration range of 100-600 ng/spot for Atenolol, Amlodipine besylate and Aspirin, and a good linear curve was displayed over the concentration vs area plot. The limit of detection (LOD) was 80 ng/spot and limit of quantitation (LOQ) was 100 ng/spot for Atenolol, Amlodipine besylate and Aspirin, respectively. HPTLC method was successfully applied to capsule dosage form and no interference from excipients was observed. The developed method was validated as per ICH guideline and was found to be specific, precise, robust and accurate. Hence this method can be useful for routine analysis of Atenolol, Amlodipine besylate and Aspirin in pure drug and capsule forms.

Keywords


Amlodipine besylate, Aspirin, Atenolol, Densitometry, High performance thin layer chromatography and Validation.

References