Sushma G Panchal¹, Arunadevi S Birajdar²*, Sayali S Pawar³, Supriya S Shendge¹, Amol A Joshi⁴

¹Assistant Professor, K. T. Patil College of Pharmacy, Osmanabad, Maharashtra, India
²Associate Professor, K.T. Patil College of Pharmacy, Osmanabad, Maharashtra, India
³Student, ASPM’s K. T. Patil College of Pharmacy, Osmanabad, Maharashtra, India
⁴Principal, K. T. Patil College of Pharmacy, Osmanabad, Maharashtra, India

*Corresponding Author: Arunadevi S Birajdar, Associate Professor, K.T. Patil College of Pharmacy, Osmanabad, Maharashtra, India.

Received: May 30, 2022; Published: July 21, 2022

Abstract

The aim of the work is to develop Analytical Method Development and Validation for Assay of Acyclovir Ointment by UV-Visible method and reverse phase high performance liquid chromatographic method for the estimation of Acyclovir in bulk and ointment formulation and validation of developed method according to ICH Q2(R1) guidelines. According to USP 2010 Analytical method development was started with preliminary studies of the Acyclovir. The Stock Solution of the drug was prepared in Acetonitrile and Water because drug freely soluble in acetonitrile. The RP-HPLC method for estimation of Acyclovir dosage form was developed. by using Phenomenex Kientex C18 column (150 mm × 4.6 mm, 5 mm) as stationary phase and Mobile Phase A - 1% Acetonitrile: 99% Phosphate Buffer pH 3.1 and Mobile Phase B: 50% Acetonitrile: 50% Phosphate Buffer pH 2.5 as mobile phase. Mobile phase was maintained at a flow rate of 1.0 ml/min the quantification was carried out. The UV detector was operated at 254 nm at 30^oC and Acyclovir eluted at RT 15.01 min. ACY was scanned by using UV-Vis spectrophotometer within 200-400 nm. The lambda max was found to be 254 nm, which was used for UV-Vis analysis of ACY. The study method was found to be precise, linear, accurate, robust, specific, stability indicating and suitable for its intended use. The developed method was validated according to ICH guidelines.

Keyword: Analytical Method Development; Validation; Assay; ICH Guidelines

References

1. AH Backett and JB Stenlake. “Practical Pharmaceutical chemistry Part 2^nd, 4^th edition”. CBS Publishers and Distributors Pvt. Ltd 275-299.
2. Merit W and Dean S. “Instrumental method of analysis”. 7^th 75-83.
3. Sharma BK. “Instrumental Method of Chemical Analysis”. 24^th Edition, Goel Publishing House, Meerut. 2005,C-3-8
4. Chatwal GR and Anand SK. “Instrumental Methods of Chemical Analysis”. 5^th Edition, Himalaya Publishing House, New Delhi, 2 (2007): 624-2.629
5. Indian Pharmacopeia, govt India Ministry of Health and family Wellfare, published by Indian Pharmacopeia Ghaziabad (2007).
6. United State Pharmacopeia and National Formulary. USP 30 NF, 2007, Asian Edition 2 (2007).
7. Manohar Potdar. “Pharmaceutical quality assurance”. Nirali Prakashan 2^nd edition (2012): 8.28- 8.31
8. Preeti Gandhi and Nilofar Momin. “Spectrophotometric estimation of acyclovir in pharmaceutical dosage forms”. Indian Journal of Pharmaceutical Sciences4 (2006): 516-517.
9. Hellen Karine Stulzer and Monika piazzon Tagliari. “Development and Validation of an RPHPLC method to Quantitate Acyclovir in Cross-Linked Chitosan Microspheres Produced by Spray Drying”. Journal of Chromatographic Science 46 (20068): 496-500.
10. Venkata Kumar. “Development and Validation of HP-HPLC method for the determination of Acyclovir in human plasma”. The International Journal of Chemical Sciences 8.1 (2010): 475-482.
11. Umesh S Dongare and Satyam Z Chemate. “Spectrophotometric determination and validation of Acyclovir in tablet dosage form”. International Journal of Pharma Tech Research4 (2012): 1840-1845.
12. Somsubhra Ghosh., et al. “Method development and validation for acyclovir in tablet dosage form by RP-HPLC”. Journal of Pharmacy Research3 (2012): 1785-1786.
13. GR Silva., et al. “Analysis of acyclovir in Vitreous humor by a validated HPLC method”. Pharmazie 68 (2013): 235-239.
14. Narayana Raju Padala and Baishaki Dey. “UV Spectrophotometric Estimation of Acyclovir in bulk and Pharmaceutical dosage forms”. Journal of Pharmaceutical and Scientific Innovation4 (2013): 30-40.
15. P Ravisankar., et al. “Development and validation of RP-HPLC method for quantitative estimation of Acyclovir in bulk drug and tablets”. Journal of Chemical and Pharmaceutical Sciences1 (2015): 73-80.
16. Swapna Velivela and Konde Abbulu. “Method development and validation of Acyclovir in Rabbit plasma by RP-HPLC”. 10.7 (2016): 509-513.
17. Yadav Purushotam Kumar. “New Analytical method development and validation of Acyclovir by RP-HPLC method”. Unique Journal of Pharmaceutical and Biological Sciences2 (2016): 20-26.
18. Prabhat Dessai and Nirupa Fatrekar. “Stability indicating method development and validation of UV method for the determination of Acyclovir in tablet dosage form”. American Journal of Pharmaceutical Sciences 9 (2018): 8955-8960.
19. Suchita V Ghumare and Varsha M Jadhav. “High pressure liquid Chromtographic method development and validation for estimation of Acyclovir in bulk and marked formulation”. International Journal of Pharmaceutical Sciences Research5 (2019): 2094.
20. Gunasekar Manoharan., et al. “Development and Validation of a Stability-Indicating RP-HPLC Method for the Estimation of Acyclovir in Bulk and Ointment Dosage Form”. International Journal of Pharmaceutical and Phytopharmacological Research1 (2019): 11-18.

Citation

Citation: Arunadevi S Birajdar., et al. “RP-HPLC and UV Method Development and Validation of Acyclovir in Bulk and Ointment Formulation". Acta Scientific Pharmaceutical Sciences 6.8 (2022): 14-24.

Copyright

Copyright: © 2022 Arunadevi S Birajdar., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.