Experimental Design Optimized Chromatographic Determination of Pseudoephedrine and Cetirizine in Bulk and Tablets

Yıl 2022, , 165 - 174, 01.09.2022

Imad Reid

https://doi.org/10.52794/hujpharm.1058051

Öz

Chromatographic separation of cetirizine and pseudoephedrine was established using cyanopropyl column and mobile phase composed of aqueous phase (20 mM ammonium acetate buffer, pH 5.5) and acetonitrile (44:56v/v) pumped at 1 mL/minute, analytes were detected at 240 nm. The linearity of the method was between 25- 135 μg/mL and 1.5 –7.5 μg/mL for pseudoephedrine and cetirizine, respectively. Pseudoephedrine and cetirizine detection limits were 5.34 and 0.13 μg/mL, respectively, whereas their quantitation limits were 16.17 μg/mL and 0.40 μg/mL for cetirizine. The method’s recoveries were (99.81% ± 0.60 for pseu- doephedrine and 100.08 ± 0.52 for cetirizine), indicating consistent good and consistent recoveries. Also low relative standard deviations (< 2%) for repeatabil- ity and intermediate precision were obtained supporting method’s high precision. Quantification of pseudoephedrine and cetirizine in bulk and combined tablet formulation was successfully carried out using the validated method.

Anahtar Kelimeler

Pseudoephedrine, Cetirizine, HPLC, Experimental design

Destekleyen Kurum

None

Kaynakça

• 1. Sweetman SC. Martindale: The Complete Drug Reference, 36th edition, Pharmaceutical Press; London, 2009.
• 2. United States Pharmacopeia: Rockville, MD, United States Pharmacopeial Convention, 2005.
• 3. Kumudhavalli MV, Saravanan C, Kumar M, Jayakar B: Determination of psuedoephedrine hydrochloride, cetirizine dihydrochloride and paracetamol uncoated tablet by RP-HPLC method. J. of Global Pharm. Tech. 2010, 2: 97–101.
• 4. Rawool ND, Venkatchalam A, Singh KH: Development and validation of a rapid RP-HPLC method for the simultaneous estimation of cetirizine and pseudoephedrine in pharmaceutical dosage forms. International Journal of Current Pharmaceutical Research 2013, 5 (1): 54-60.
• 5. Likar MD, Mansour HL, Harwood JW: Development and validation of a dissolution test for a once-a-day combination tablet of immediate-release cetirizine dihydrochloride and extended-release pseudoephedrine hydrochloride. Journal of Pharmaceutical and Biomedical Analysis 2005, 39: 543–551.
• 6. Nalini CN, Kavitha K: Simultaneous determination of pseudoephedrine hydrochloride and cetirizine hydrochloride by reverse phase high performance liquid chromatography. Indian Journal of Pharmaceutical Sciences 2006, 68 (1):95-97.
• 7. Tan ZR, Ouyang DS, Zhou G and Wang LS., Li Z, Wang D, Zhou HH: Sensitive bioassay for the simultaneous determination of pseudoephedrine and cetirizine in human plasma by liquid-chromatography-ion trap spectrometry. Journal of Pharmaceutical and Biomedical Analysis 2006, 42: 207–212.
• 8. Ma M, Feng F, Sheng Y, Cui S, Liu H: Development and evaluation of an efficient HPLC/MS/MS method for the simultaneous determination of pseudoephedrine and cetirizine in human plasma: application to Phase-I pharmacokinetic study. Journal of Chromatography B 2007, 846: 105–111.
• 9. Karakus S, Kucukguzel, I, Kucukguzel SG: Development and validation of a rapid RP-HPLC method for the determination of cetirizine or fexofenadine with pseudoephedrine in binary pharmaceutical dosage forms. Journal of Pharmaceutical and Biomedical Analysis 2008, 46: 295–302.
• 10. Abu-Shandi K, Mohammed QD, Saket MM and Qaisi AM, Deabas F, Massadeh AM, Al-Ayed O, Al-Momani L, Abu-Nameh ESM: Simultaneous determination of cetirizine and pseudoephedrine combined in tablet dosage form by high performance liquid chromatography. Jordan Journal of Pharmaceutical Sciences 2013, 6 (2):188-202.
• 11. Hadad GM, Emara S, Mahmoud WMM: Development and validation of a stability-indicating RP-HPLC method for the determination of paracetamol with dantrolene or/and cetirizine and pseudoephedrine in two pharmaceutical dosage forms. Talanta 2009, 79: 1360–1367.
• 12. Mahgoub H, Gazy AA, El-Yazbi FA and El-Sayed MA, Youssef RM: Spectrophotometric determination of binary mixtures of pseudoephedrine with some histamine H1 receptor antagonists using derivative ratio spectrum method. Journal of Pharmaceutical and Biomedical Analysis 2003, 31: 801–809.
• 13. Sahu LK, Gupta JK, Patro SK: Concurrent spectrophotometric assay of pseudoephedrine and cetirizine from combination tablets. Asian Journal of Chemistry 2004, 16(2): 1149-1152.
• 14. Makhija SN, Vavia PR: Stability indicating HPTLC method for the simultaneous determination of pseudoephedrine and cetirizine in pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis 2001, 25: 663–667.
• 15. Alnajjar AO, Idris AM: Development of a CZE method for the quantification of pseudoephedrine and cetirizine. Journal of Chromatographic Science 2013, 1–5.
• 16. ICH, Q2(R1) Validation of analytical procedures: text and methodology. International Conference on Harmonization, Geneva, 2005.
• 17. Dolan JW: Ion Pairing — Blessing or Curse? LCGC North America 2008, 26(2): 170-174.
• 18. Abu Reid IO: Concurrent chromatographic determination of pseudoephedrine and loratadine from combination syrups and tablets. Future Journal of Pharmaceutical Sciences 2021, 7:138.
• 19. Montgomery DC: Design and analysis of experiments, 4th edition, New York: John Wiley, 1997.
• 20. Mazak K, Noszal B: Physicochemical properties of zwitterionic drugs in therapy. Chemistry Europe 2020, 1-11.
• 21. Jenke JR: Chromatographic method validation: a review of current practices and procedures. Part III. Ruggedness, revalidation and system suitability. J Liq Chromatogr Relat Technol 1996, 19(12):1873-1891.