Priyanka S. Yadav, Ashok A. Hajare, Kiran S. Patil
Priyanka S. Yadav1, Ashok A. Hajare1*, Kiran S. Patil2
1Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur - 416008, Maharashtra, India.
2Department of Pharmaceutical Quality Assurance, Tatyasaheb Kore College of Pharmacy, Warnanagar, Kolhapur - 416113, Maharashtra, India.
Volume - 15,
Issue - 6,
Year - 2022
Doxazosin mesylate (DX) is an antihypertensive agent belonging to BCS class II. There is no reported literature available on development of spectrophotometric method for its analysis in bulk and pharmaceutical dosage forms using 0.1N HCl. Thus, attempt was made to develop and validate a new UV spectrophotometric method using 0.1N HCl as the solvent for its quantitative estimation in tablets that would be fast, simple, accurate, and sensitive. DX had a maximum absorbance wavelength of 245 nm and was linear with a correlation coefficient (R2) of 0.9981 across the concentration range of 2-14 µg/mL. The present method was utilized to determine the drug content of two commercial brands namely; brand I and brand II. The estimated amount of DX was 99.13% and 99.02% in these brands, respectively. The proposed method generated results that confirm the label claim and was accurate, precise, sensitive, and rugged during its validation study. The accuracy of the technique was tested using recovery research at three different levels, namely 80%, 100%, 120%, and the percent recovery rate was determined between 98% and 102% suggesting that the proposed approach is accurate. Precision and robustness were within the acceptable limits, complying with ICH standards. The proposed method could be used to quantify DX in API and dosage forms.
Cite this article:
Priyanka S. Yadav, Ashok A. Hajare, Kiran S. Patil. Development and Validation of UV Spectrophotometric Method for Doxazosin Mesylate in Bulk and Tablets. Research Journal of Pharmacy and Technology. 2022; 15(6):2675-0. doi: 10.52711/0974-360X.2022.00447
Priyanka S. Yadav, Ashok A. Hajare, Kiran S. Patil. Development and Validation of UV Spectrophotometric Method for Doxazosin Mesylate in Bulk and Tablets. Research Journal of Pharmacy and Technology. 2022; 15(6):2675-0. doi: 10.52711/0974-360X.2022.00447 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-6-51
1. The United States Pharmacopeia. The National Formulary. (USP35-NF30); Rockville, Md.: United States Pharmacopoeial Convention. Doxazosin Official Monograph. 2012; 2975- 2977.
2. Cha KH, Tran TH et al. pH-independent sustained release matrix tablet containing doxazosin mesylate: Effect of citric acid. Archives of Pharmacal Research. 2010;33(12),2003-2009. doi.org/10.1007/s12272-010-1216-z
3. Messerli FH. Doxazosin and congestive heart failure. Journal of the American College of Cardiology. 2001;38(5):1295-96. doi.org/ 10.1016/s0735-1097(01)01534-0
4. Andrzej W, Przemyslaw G et al. Doxazosin in the current treatment of hypertension. Expert Opinion on Pharmacotherapy. 2008; 9(4):625-633. doi.org/ 10.1517/146565188.8.131.525
5. Srivastava A, Jain M et al. Determination of doxazosin in different matrices: a review. International Journal of Advanced Chemistry. 2014;2(2):109-116. doi.org/ 10.14419/ijac.v2i2.3054
6. Siddiqui MR, Alothman ZA et al. Analytical techniques in pharmaceutical analysis: a review. Arabian Journal of Chemistry. 2017; 10:S1409–S1421. doi.org/10.1016/j.arabjc.2013.04.016
7. Food and Drug Administration. Analytical procedures and methods validation for drugs and biologics: guidance for industry. Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration. 2015:1-3.
8. Guideline, ICH Harmonised Tripartite. ICH topic Q2 (R1) Validation of analytical procedures: text and methodology. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use 2005.
9. Branch SK. Guidelines from the International Conference on Harmonisation (ICH). Journal of Pharmaceutical and Biomedical Analysis. 2005;38(5): 798-805. doi: 10.1016/j.jpba.2005.02.037
10. Singh S, Mishra A et al. Simple ultraviolet spectrophotometric method for the determination of etoricoxib in dosage formulations. Journal of Advanced Pharmaceutical Technology & Research. 2012; 3(04): 237-240. doi.org/10.4103/2231-4040.104715
11. Patel KN, Patel JK et al. A validated method for development of atovaquone as API and tablet dosage forms by UV spectroscopy. Pharmaceutical Methods. 2010;1(1):61-64. doi.org/10.4103/2229-4708.72234
12. Chakraborty S, Sharmin S et al. Stability-indicating UV/Vis spectrophotometric method for diazepam, development and validation. Indian Journal of Pharmaceutical Sciences. 2018;80(2):366-373. doi.org/10.4172/pharmaceutical-sciences.1000366
13. Bhusnure OG, Makanikar VG et al. Development, validation and stability study of UV spectrophotometric method for determination of Sofosbuvir in bulk and pharmaceutical dosage forms. Journal of Pharmacy Research. 2017;11(7):847-849.
14. Kansagra P, Sanghvi G et al. Development and validation of stability indicating UV spectrophotometric method for the determination of Ketoconazole both in bulk and marketed dosage formulations. Pharm Analysis & Quality Assurance. 2013;1:1-5
15. Guideline, ICH Harmonised Tripartite. Stability testing of new drug substances and products. Q1A (R2), current step. 2003 Feb;4:1-24.
16. Belal TS, Mahrous MS et al. Validated HPTLC method for the simultaneous determination of alfuzosin, terazosin, prazosin, doxazosin and finasteride in pharmaceutical formulations. Analytical Chemistry Research. 2014; 1: 23-31. doi.org/10.1016/j.ancr.2014.06.004
17. Chanda I, Bordoloi R et al. Development and validation of UV-spectroscopic method for estimation of niacin in bulk and pharmaceutical dosage form. Journal of Applied Pharmaceutical Science. 2017; 7(09): 081-084. doi.org/10.7324/JAPS.2017.70911
18. Bebawy LI, Moustafa AA et al. Stability-indicating methods for the determination of doxazosin mesylate and celecoxib. Journal of Pharmaceutical and Biomedical analysis. 2002;27(5):779-793. doi.org/10.1016/s0731-7085(01)00523-4
19. Powar TA, Hajare AA. Development and validation of an HPLC- UV method for the determination of Melphalan from lyophilized nanosuspension. Indian Journal of Pharmaceutical Education and Research 2019; 53(02):316-324. doi.org/ 10.5530/ijper.53.2.40
20. Patil KS, Pore YV et al. Spectrophotometric estimation of zolpidem in tablets. Journal of Pharmaceutical Sciences and Research. 2010;2(1):1-4
21. Hajare AA, Powar TA et al. Development and validation of RP-HPLC method for determination of doxorubicin hydrochloride from vacuum foam dried formulation. Research Journal of Pharmacy and Technology. 2016; 9(9):1265-1269. doi.org/ 10.5958/0974-360X.2016.00259.6
22. Kirtawade R, Salve P et al. Simultaneous UV-spectrophotometric method for estimation of atenolol and losartan potassium in tablet dosage form. Asian Journal of Research in Chemistry. 2010;3(4):1050-1053
23. Yadav PS, Kondawar MS et al. Enhancement of dissolution properties of candesartan using liquisolid technique. International Journal of Advances in Pharmaceutical Research. 2013;4(02)2503-2513