Author(s):
Arun Maruti Kashid, Amey Chandrakant Khilare, Shivanjali Balasaheb Sable
Email(s):
arunkashid2006@gmail.com
DOI:
10.52711/2231-5675.2023.00042 
Address:
Arun Maruti Kashid1*, Amey Chandrakant Khilare2, Shivanjali Balasaheb Sable2
1Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India - 41.
2 Department of Pharmaceutical Quality Assurance, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India – 41.
*Corresponding Author
Published In:
Volume - 13,
Issue - 4,
Year - 2023
ABSTRACT:
A simple, precise, accurate stability-indicating method was developed and validated for Acebrophylline in bulk and tablet dosage form. The chromatographic separation was achieved by using Methanol: Acetonitrile: Acetone: Formic acid (4:4:2:0.1 v/v/v/v) as mobile phase and UV detection at 272nm. The retention factor for Acebrophylline was found to be 0.74±0.10. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation, and robustness as per ICH guidelines. Results were found to be linear in the concentration range of 400-2400ng band -1 with a correlation coefficient of 0.9921. The % assay was found to be 102.4±5. The drug was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis, and thermal degradation. The developed method can be used for the quantification of drug in the dosage form, bulk drug as well as for routine analysis in quality control laboratories.
Cite this article:
Arun Maruti Kashid, Amey Chandrakant Khilare, Shivanjali Balasaheb Sable. Stability Indicating HPTLC Method Development and Validation for Acebrophylline in Bulk and its Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(4):255-0. doi: 10.52711/2231-5675.2023.00042
Cite(Electronic):
Arun Maruti Kashid, Amey Chandrakant Khilare, Shivanjali Balasaheb Sable. Stability Indicating HPTLC Method Development and Validation for Acebrophylline in Bulk and its Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(4):255-0. doi: 10.52711/2231-5675.2023.00042 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-4-6
REFERENCES:
1. Arjun, P. and Nair, V. Acebrophylline. Kerala Medical Journal. 2011; 4(4): 127-128.
2. Attimarad, M., Ahmed, K.M., Aldhubaib, B.E. and Harsha, S. High-performance thin layer chromatography: A powerful analytical technique in pharmaceutical drug discovery. Pharmaceutical methods. 2011; 2(2): 71-75.
3. Kulkarni, R.N., Pandhare, R.B., Deshmukh, V.K., Mohite, P.B. and Pawar, A.R. High-performance thin layer chromatography: A powerful analytical technique in pharmaceutical drug discovery. Journal of Pharmaceutical and Biological Sciences. 2021; 9(1): 7.
4. Sherma, J. Review of HPTLC in drug analysis: 1996-2009. Journal of AOAC International. 2010; 93(3): .754-764.
5. Yadav, R., Khan, S., Sharma, R., Nagar, P., Shriwas, S. and Patel, R. Stability indicating RP-HPLC method development and validation for simultaneous quantification of fexofenadine & acebrophylline drug in bulk and tablet dosage form. International Journal of Pharmaceutical Sciences & Medicine. 2023; 8(1): 8-35.
6. Bhavik, S. and Agarwal, S.K. RP-HPLC Method Development and Validation for Estimation of Acebrophylline. Asian Journal of Pharmaceutical Research and Development. 2018; 6(6): 56-59.
7. Vekaria, H.J. and Jat, R.K. Analytical Method Development and Validation for Simultaneous Estimation of Acebrophylline and Montelukast Sodium in their Pharmaceutical Dosage Form. Journal of Basic and Applied Scientific Research. 2011; 1(11): 1884-1890.
8. Madhuri, S. and Bhawar, H.S. A review on method development on the estimation of Acebrophylline and Doxophylline, World Journal of Pharmaceutical Research. 2019; 8(11): 644-657.
9. Shewiyo, D.H., Kaale, E.A.K.K., Risha, P.G., Dejaegher, B., Smeyers-Verbeke, J. and Vander Heyden, Y. HPTLC methods to assay active ingredients in pharmaceutical formulations: A review of the method development and validation steps. Journal of Pharmaceutical and Biomedical Analysis. 2012; 66: 11-23.
10. Kaur, I., Wakode, S. and Singh, H.P. Development and validation of a stability-indicating high-performance thin layer chromatography (HPTLC) method for estimation of canagliflozin in bulk and pharmaceutical dosage form. Journal of Applied Pharmaceutical Science. 2016; 6(5): 51-57.
11. Guideline, ICH. Validation of Analytical Procedures: Text and Methodology. 2005; Q2 (R1), 1(20), 05.
12. Geetha, G., Raju, K.N.G., Kumar, B.V. and Raja, M.G. Analytical method validation: an updated. Review. International Journal of Advances in Pharmacy. 2012; 1: 64-71.
13. Guideline, ICH, 2005. Validation of Analytical Procedures: Text and Methodology. Q2 (R1), 1(20), 05.
14. Ravisankar, P., Navya, C.N., Pravallika, D. and Sri, D.N. A review on step-by-step analytical method validation Sherma, J. Review of HPTLC in drug analysis: 1996-2009. Journal of Association of Official Agricultural Chemists. 2015; 93(3): 754-764.
15. Bakshi, M. and Singh, S., 2002. Development of validated stability-indicating assay methods—a critical review. Journal of Pharmaceutical and Biomedical Analysis, 28 (6), 1011-1040.
16. Kaur, I., Wakode, S. and Singh, H.P. Development and validation of a stability-indicating high-performance thin layer chromatography (HPTLC) method for estimation of canagliflozin in bulk and pharmaceutical dosage form. Journal of Applied Pharmaceutical Science. 2016; 6(5): 51-57.
17. Sehrawat, R., Maithani, M. and Singh, R. Regulatory aspects in development of stability-indicating methods: a review. Chromatographia. 2010; 72 (1): 01-06.