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Published on:May 2021
Indian Journal of Pharmaceutical Education and Research, 2021; 55(2):598-606
Original Article | doi:10.5530/ijper.55.2.99

RP-HPLC Accelerated Degradation Method Development and Validation for Determination of Amlodipine and Atorvastatin in Combination Dosage Form of Tablet

Authors and affiliation (s):

Anuruddha Rajaram Chabukswar1, Pramod Hindurao Sakpal2,*

1Department of Pharmaceutical Chemistry, School of Pharmacy, Dr. Vishwanath Karad MIT World Peace University, Kothrud, Pune, Maharashtra, INDIA.

2Department of Pharmaceutical Chemistry, Marathwada Mitra Mandal’s College of Pharmacy, Savitribai Phule Pune University, Pune, Maharashtra, INDIA.


Aim: The Cost effective, Accurate, Precise Accelerated degradation method has been developed for determination of Atorvastatin and Amlodipine in combination dosage form of tablet and validated as directed by ICH guidelines. Objectives: To develop and validate analytical method which can be easily adoptable in frequent analysis of Amlodipine and Atorvastatin combinations in the laboratories. Materials and Methods: The 0.02 M potassium dihydrogen phosphate: acetonitrile: methanol (30:10:60 v/v/v) was used as mobile phase and pH 4 adjusted using ortho phosphoric acid at flow rate 1.0 ml/min. The column used for method development was Octadecylsilane-C18 (5 μm, 25 cm × 4.6mm, i. d.). The peaks obtained in the chromatogram were well resoluted. The scanning wavelength used was 244 nm with PDA detector. Results: The linearity for both the drugs was found between 05 - 30 μg/ml for both drugs with regression coefficient equation 0.995 and 0.999 at retention time 8.32 min and 11.09 min for Amlodipine and Atorvastatin respectively. The results obtained were statistically validated as directed by ICH guidelines and was found satisfactory. Conclusion: The developed and validated method was found to be very specific, accurate and precise. It can be utilized for routine analysis of combined dosage form of Amlodipine and Atorvastatin in the laboratory.

Key words: Amlodipine, Atorvastatin, RP-HPLC, ICH Guidelines, PDA Detector, Validation.



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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.


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