A COMPARATIVE STUDY OF GENERIC VS BRANDED DRUG OF LOSARTAN POTASSIUM USING UV-VISIBLE SPECTRO-PHOTOMETER
Author
Dr. D.NAGAVALLI , I.HEERA ,G. MONIKA, R.RITHIKA,B.SRIDEVI, M.VAISHNAVI ,Mr. P.NANTHAGOPAL
Abstract
Reliable analytical methods are essential for routine pharmaceutical quality control and comparative evaluation of marketed products. This study aimed to develop and validate a rapid, direct UV–Visible spectrophotometric method for quantitative determination of losartan potassium and its application to selected marketed 25-mg tablets. Losartan potassium was analysed in distilled water using a double-beam UV–Visible spectrophotometer at 247 nm linear at a concentration range of 10–60 µg/mL. The method was predicting excellent linearity (R² = 0.9999), with regression equation y = 0.0275x + 0.0007. LOD and LOQ were 0.6453 and 1.9554 µg/mL, respectively. Accuracy, precision, solution stability and ruggedness were effectiveness. Assay values for five marketed formulations ranged from 89.467% to 109.437%. The method provides a rapid, economical, reproducible and accessible approach for routine quality assessment of losartan potassium tablets.
Keywords
Losartan potassium; UV–Visible spectrophotometry; analytical method validation; generic tablets.
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References
- International Council for Harmonisation. ICH Q2(R2): Validation of analytical procedures. Geneva: ICH; 2023.
- International Council for Harmonisation. ICH Q14: Analytical procedure development. Geneva: ICH; 2023.
- Lastra OC, Lemus IG, Sánchez HJ, Pérez RF. Development and validation of an UV derivative spectrophotometric determination of losartan potassium in tablets. J Pharm Biomed Anal. 2003;33(2):175-180.
- Rahman N, Siddiqui MR, Azmi SNH. Development and validation of kinetic spectrophotometric method for the determination of losartan potassium in pure and commercial tablets. J Chin Chem Soc. 2006;53(3):735-743.
- Rathee P, Rathee S, Chaudhary H, Rathee D. Development and validation of a stability-indicating UV-spectrophotometric method for the estimation of losartan potassium in bulk and tablet dosage form. J Pharm Res. 2008;1(2):188-192.
- Patil PR, Rakesh SU, Dhabale PN, Burade KB. Simultaneous UV spectrophotometric method for estimation of losartan potassium and amlodipine besylate in tablet dosage form. Asian J Res Chem. 2009;2(1):183-187.
- Kathiresan K, Gothandaraman S, Swamivel Manickam M, Mathan Kumar S, Manavalan R. Analytical method development and validation of losartan potassium tablet by RP-HPLC. Rasayan J Chem. 2008;1(3):521-525.
- Nagavalli D, Vaidhyalingam V, Santha A, Sankar ASK, Divya. Simultaneous spectrophotometric determination of losartan potassium, amlodipine besilate and hydrochlorothiazide in pharmaceuticals by chemometric methods. Acta Pharm. 2010;60(2):141-151.
- Jia JY, Zhang MQ, Liu YM, et al. Pharmacokinetics and bioequivalence evaluation of two losartan potassium 50-mg tablets: a single-dose, randomized-sequence, open-label, two-way crossover study in healthy Chinese male volunteers. Clin Ther. 2010;32(7):1387-1395.
- Araujo-Fernandez AS, Uribe-Villarreal JC, Perez-Chauca E, et al. Validation of a UV spectrophotometric method to quantify losartan potassium in tablets from the dissolution test at pH 1.2, 4.5 and 6.8. J Pharm Pharmacogn Res. 2022;10(2):310-317.
- Binh TT, Phuong Tram LT, Van Hop N, et al. Simultaneous determination of hydrochlorothiazide and losartan potassium in pharmaceutical product by UV-Vis spectrophotometric method with Kalman filter algorithm. J Anal Methods Chem. 2021;2021:2754133.
- Vasanth Kumar PM, Srinivasa Rao A. Derivative zero and first order UV spectrophotometric method for quantification of losartan potassium. Int J Acad Res. 2024;11(1):73-78.
- Rangari NT, Puranik PK, Chaudhari SR. Spectrophotometric determination of losartan potassium in pure form and in tablet dosage form. Int J Pharm Tech Res. 2015;8(1):142-145.
- Moen MD, Wagstaff AJ. Losartan: a review of its use in stroke risk reduction in patients with hypertension and left ventricular hypertrophy. Drugs. 2005;65(18):2657-2674.