DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL AND THEIR RELATED SUBSTANCES IN COMBINED TABLET DOSAGE FORM

  • Urvesh Mahendrabhai Patel Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa 388421, Ta. Petlad, Dist. Anand, Gujarat, India.
  • Avani B. Chokshi Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa 388421, Ta. Petlad, Dist. Anand, Gujarat, India.
  • Pritesh R. Desai Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa 388421, Ta. Petlad, Dist. Anand, Gujarat, India.

Abstract

Objective: Development of RP-HPLC method for determination of Hydrochlorothiazide (HCTZ), Olmesartan medoxomil (OLM) and their related substances in combined tablet dosage form and validation of the developed method.

Methods: Gradient mobile phase system was used for estimation of drug contents and their related substances. Mobile phase A contained the mixture of Acetonitrile and 15 mM Phosphate buffer (pH adjusted to 3.4 with orthophosphoric acid) in the ratio of 20:80. Mobile phase B contained the same mixture in the ratio of 80:20. Chromatographic separation was carried out at the mobile phase flow rate of 0.8 mL/min using C18 Phenomenax inplace of Enable (250 × 4.6 mm) 5 μm column and detection was made at 254 nm.

Results: The linearity of developed method was tested in the range of 62.5-187.5 μg/mL for Hydrochlorothiazide, 100-300 μg/mL for Olmesartan medoxomil, 1-1.8 μg/mL for Hydrochlorothiazide. The % recovery was found to be 99.88-100.67 % (HCTZ), 99.14-99.91 % (OLM), 99.11-100.71% (HCTZ-IMP) and 98.13-100.83% (OLM-IMP). The assay of marketed formulation was found to be 99.78% (HCTZ) and 99.26% (OLM).

Conclusion: A simple, precise and accurate RP-HPLC method was developed for determination of Hydrochlorothiazide, Olmesartan medoxomil and their related substances.

 

Keywords: Hydrochlorothiazide (HCTZ), Olmesartan medoxomil (OLM), Hydrochlorothiazide Related Impurity (HCTZ-IMP), Olmesartan medoxomil Related Impurity (OLM-IMP), Reversed phase high performance liquid chromatography (RP-HPLC).

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Patel, U. M., A. B. Chokshi, and P. R. Desai. “DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL AND THEIR RELATED SUBSTANCES IN COMBINED TABLET DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 6, no. 9, 1, pp. 318-23, https://innovareacademics.in/journals/index.php/ijpps/article/view/2067.
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