A NEW VALIDATED STABILITY-INDICATING DIRECT HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF ROSIGLITAZONE ENANTIOMERS IN THE PRESENCE OF ITS DEGRADATION PRODUCTS

  • BYRAN GOWRAMMA Department of Pharmaceutical Chemistry, JSS College of Pharmacy, (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Nilgiris, Tamil Nadu, India.
  • SUBRAMANIYAN NAIYANAR MEYYANATHAN Department of Pharmaceutical Analysis, JSS College of Pharmacy, (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Nilgiris, Tamil Nadu, India.
  • BASAWAN BABU Department of Pharmaceutical Analysis, JSS College of Pharmacy, (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Nilgiris, Tamil Nadu,
  • NAGAPPAN KRISHNAVENI Department of Pharmaceutical Analysis, JSS College of Pharmacy, (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Nilgiris, Tamil Nadu, India.

Abstract

Objective: In the present study, an isocratic chiral reverse-phase high-performance liquid chromatography method was developed and the resolution of the drug and complete separation from its degradation products were successfully achieved.


Methods: An isocratic method developed with a Phenomenex Lux 5 μ Cellulose 1 (150 mm×4.6 mm i.d., 5 μ) using UV detector at wavelength of 220 nm, with a mobile phase consisting of methanol:0.1% diethylamine (60:40% v/v) and a flow rate of 1 ml/min. The drug was subjected to alkaline, acidic, neutral, oxidative, and photolytic to apply stress conditions. The stressed samples were analyzed by the proposed method.


Results: The described method was linear over the range of 3–7 μg/ml for R-enantiomer and 9–21 μg/ml of S-enantiomer, respectively. The limit of detection and limit of quantification of R and S enantiomers were found to be 0.56 μg/ml and 0.18 μg/ml, respectively.


Conclusion: The method provides good sensitivity and excellent precision and reproducibility. The developed method can be applied in the quality control of drug products.

Keywords: Stability-indicating method, Validation, Chiral, Rosiglitazone.

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GOWRAMMA, B., S. N. MEYYANATHAN, B. BABU, and N. KRISHNAVENI. “A NEW VALIDATED STABILITY-INDICATING DIRECT HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF ROSIGLITAZONE ENANTIOMERS IN THE PRESENCE OF ITS DEGRADATION PRODUCTS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 3, Feb. 2019, pp. 64-67, https://innovareacademics.in/journals/index.php/ajpcr/article/view/24960.
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