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; SUBRAMANIYAN NAIYANAR MEYYANATHAN; BASAWAN BABU; NAGAPPAN KRISHNAVENI

doi:10.22159/ajpcr.2019.v12i3.24960

Authors

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.

DOI:

https://doi.org/10.22159/ajpcr.2019.v12i3.24960

Keywords:

Stability-indicating method, Validation, Chiral, Rosiglitazone

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.

Downloads

Download data is not yet available.

References

Ahuja S. Impurities Evaluation of Pharmaceuticals. New York: Marcel Dekker Inc.; 1998.

Ahuja S, Alsante, KM. Handbook of Isolation and Characterisation of Impurities in Pharmaceuticals. San Diego, USA: Academic Press; 2003.

Baaske DM, DeMay JF, Latona CA, Mirmira S, Sigvardson KW. Stability of nicardipine hydrochloride in intravenous solutions. Am J Health Syst Pharm 1996;53:1701-5.

Nagappan K, Yamjala K, Sathyaseelan M, Byran G. Stability evaluation of tartrazine by liquid chomatography-diode array detector and high-resolution electron spray ionization quadrupole time-offlight mass spectrometry/mass spectrometry analysis. Asian J Pharm Clin Res 2017;10:295-9.

Daraghmeh N, Al-Omari M, Badwan AA, Jaber AM. Determination of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC. J Pharm Biomed Anal 2001;25:483- 92.

Pettersson C, Persson B. In: Katz E, Eksteen R, Schoenmakers P, Miller N, editors. Handbook of HPLC. New York: Marcel Dekker; 1998. p. 669.

Subramanian G, editors. A Practical Approach to Chiral Separations by Liquid Chomatography. Weinheim, Germany: Verlagsgesellschaft MBH; 1994.

Gowramma B, Meyyanathan SN. Stability indicating chiral HPLC method for the estimation of pioglitazone enantiomers in pharmaceutical formulation. Asian J Pharm Clin Res 2015;8:63-6.

Singh S, Baksh M. Development of validated stability-indicating assay methods-critical review. J Pharm Biomed Anal 2002;28:1011.

International Conference on Harmonisation. Stability Testing of New Drug Substances and Products Q1A. Geneva: International, Conference on Harmonization, IFPMA; 1993.

Ritchie JA, Truelove SC. Comparison of various treatments for irritable bowel syndrome. Br Med J 1980;281:1317-9.