Author(s): Bhavana. G, Indira Priyadarshini. G, Apuroopa

Email(s): bhavana.hcop@gmail.com

DOI: 10.5958/2231-5675.2020.00038.1   

Address: Bhavana. G*, Indira Priyadarshini. G, Apuroopa
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur-522002 A. P. India.
*Corresponding Author

Published In:   Volume - 10,      Issue - 4,     Year - 2020


ABSTRACT:
The aim of the present work is to develop a new, simple, sensitive, accurate and analytical method of developing and validating the stability indicating estimation of felodipine in pharmaceutical tablet dosage form using RP-HPLC. The API was supplied by Aurobindo Pharma Ltd, Hyderabad. The chromatographic separation was done with Inertsil ODS _2 C_18 (100 x 4.6mm, 3µ) using HPLC Shimadzu (2010 CHT) instrument with LC solutions software. The suitable wavelength for the determination of felodipine is 238nm where it gave a good sensitivity for the assay using UV-Visible spectrophotometer. The mobile phase was optimized to Buffer: Acetonitrile: Methanol in proportion 2:2:1 v/v respectively. The method was performed with flow rates 1ml/min. Temperature was maintained at Ambient. Standard deviation and %RSD were calculated and obtained as 0.3% respectively. LOD and LOQ were found to be 0.56µg/ml, 1.71µg/ml respectively. The Accuracy i.e, %Recovery for 50, 100 and 150% levels are obtained as 98.13%, 99.56%, 98.52% respectively. The % degradation results were within the limits and the method was validated.


Cite this article:
Bhavana. G, Indira Priyadarshini. G, Apuroopa. Method Development and Validation of Stability Indicating RP-HPLC for the Estimation of Felodipine PR Tablets. Asian J. Pharm. Ana. 2020; 10(4):207-212. doi: 10.5958/2231-5675.2020.00038.1

Cite(Electronic):
Bhavana. G, Indira Priyadarshini. G, Apuroopa. Method Development and Validation of Stability Indicating RP-HPLC for the Estimation of Felodipine PR Tablets. Asian J. Pharm. Ana. 2020; 10(4):207-212. doi: 10.5958/2231-5675.2020.00038.1   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2020-10-4-7


REFERENCES:
1.    K. Basavaiah et al, High Performance Liquid Chromatography for the specific determination of Anti Hypersensitive drug felodipine in Pharmaceutical formulations.
2.    Neil MJ. The Merck Index. Merck Research Laboratories. Whitehouse Station, NJ; 2006
3.    Basavaiah K, Chandrashekar U, Gowda P. Titrimetric and spectrophotometric assay of felodipine in tablets using bromate-bromide, methyl orange and indigo carmine reagents. J Serbian Chem Soc 2005;7: 969-78
4.    Dru JD, Hsieh JY, Matuszewski BK, Dobrinska MR. Determination of felodipine, its enantiomers and a pyridine metabolite in human plasma by capillary gas chromatography with mass spectrometric detection. J Chromatogr B: Biomed Sci Appl 1995;666: 259-67
5.    Gedil F, Ustun O, Atay O. Quantitative determination of felodipine in pharmaceuticals by high pressure liquid chromatography and UV spectroscopy, Turkish. J Pharm Sci 2004;1: 65-76.
6.    Basavaiah K., Chandrashekar U., Prameela HC. Determination of felodipine in bulk drug and in tablets by high performance liquid chromatography. Ind J Chem Tech 2003;10: 454-6.
7.    Nataraj KS, Suresh SK, Duza M, Badrud K, Teddy K. Method validation and estimation of felodipine in pure and capsule dosage form by RP-HPLC. J Pharm Res 2011;4: 2822.
8.    Cardoza RM, Amin PD. A stability indicating LC method for felodipine. J Pharm Biomed Anal 2002;27: 711-8.
9.    Gurdeep R. Chatwal, Sham K. Anand, Instrumental Methods of Chemical Analysis, Pg 2.566-2.638 (2007)
10.    Dr.S. Ravi Shankar, Text book of Pharmaceutical analysis, Fourth edition, Pg 13.1-13.2
11.    B.k Sharma, Instrumental methods of chemical analysis, Introduction to analytical chemistry, 23rd Edition Goel publication, Meerut, (2007)
12.    Malvia R, Bansal V, Pal O. P and Sharma P. K. A Review of High Performance Liquid Chromatography. Journal of Global Pharma technology (2010)
13.    David G. Watson. Pharmaceutical Analysis, A text book for Pharmacy students and Pharmaceutical Chemists. Harcourt Publishers Limited; 2nd Ed., Pg 221-232.
14.    Remingtonn’s The Sciences and Practise of Pharmacy, 20th Edition (2000)
15.    Connors Ka. A Textbook of Pharmaceutical Analysis, Wiley intersciences Inc; Delhi, 3rd Ed, Pg 373-421, (1994)
16.    ICH Validation of Analytical Procedures: Text and Methodology Q2 (R1). International Conference on Harmonization; 2005.
17.    Lindholm.J, Development and Validation of HPLC Method for Analytical and Preparative purpose. Acta Universitatis Upsaliensis, pg. 13-14, (2004).
18.    M. Mathrusri Annapurna et al, A simple stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Felodipine in tablet dosage forms.
19.    Manoj Kumar et al,: A simple RP- HPLC method was developed and validated for the quantification of Felodipine Impurity A, B and C in Felodipine solid dosage form and in drug substance.
20.    ICH Stability Testing of New Drug Substances and Products Q1A (R2). International Conference on Harmonization; 2003.
21.    Douglas A Skoog, F. James Holler, Timothy A. Niemen, Principles of Instrumental Analysis Pg 725-760.
22.    Indian Pharmacopoeia, Indian Pharmacopoeial Commission, Controller of Publication, Government of India, Ministry of health and Family Welfare, Ghaziabad, India, 2 (2010) 1657-1658.
23.    British Pharmacopoeia, The British Pharmacopoeial Commission, the stationary office, UK, London, 1408-1409 2 (2011).

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