STABILITY INDICATING CHIRAL HPLC METHOD FOR THE ESTIMATION OF PIOGLITAZONE ENANTIOMERS IN PHARMACEUTICAL FORMULATION

  • B Gowramma (A Constituent College of JSS University, Mysore) JSS College of Pharmacy, udhagamandalam
  • Sn Meyyanathan (A Constituent College of JSS University, Mysore) JSS College of Pharmacy, udhagamandalam

Abstract

Objective: A stability indicating chiral high performance liquid chromatographic (HPLC) method was developed and validated for the separated (S)
and (R) pioglitazone in raw material and its determination in the presence of degradation products formed during forced degradation studies.
Methods: In the present study, an isocratic normal phase-HPLC method was developed with stationary phase as ACI Cellu 1 (150 mm × 4.6 mm i.d.,
5  μ)  column  and  n-hexane:  N-propyl  alcohol  (80:20,  V/V)  as  mobile  phase.  The  entire  study  was  performed  using  1.0  ml/minute  as  flow  rate  and 
the detection wavelength at  233 nm. The pioglitazone (R and S) was exposed to various stress condition such as hydrolytic (acid and base), neutral, 
oxidative, and photolytic. The stressed samples were analyzed by the proposed method.
Result:  The  described  method  was  linear  over  the  range  of  5-15 µg/ml  for  R-pioglitazone  and  4-14 µg/ml  for  S-pioglitazone.  The  limit  of  detection 
and limit of quantification of S-pioglitazone and R-pioglitazone were found to be 1.4 μg/ml and 4.26 μg/ml, respectively. The recovery study of S and 
R-Pioglitazone from tablets formulation ranged from 97.14% to 100.04%, respectively.
Conclusion: The developed method can be applied in the quality control of drug products.
Keywords: Stability-indicating method, Validation, Chiral, Pioglitazone.

Author Biographies

B Gowramma, (A Constituent College of JSS University, Mysore) JSS College of Pharmacy, udhagamandalam
Pharmaceutical Chemistry
Sn Meyyanathan, (A Constituent College of JSS University, Mysore) JSS College of Pharmacy, udhagamandalam
Pharmaceutical Analysis

References

1. Martindale. The Extra Pharmacopoeia; The pharmaceutical society of Great Britain; The pharmaceutical Press, London, 1982.
2. Gerald Gübitz, Martin G Schmid. Methods in Molecular Biology; Chiral separations methods and protocols, Austria, 2004.
3. Timothy J Ward. Chiral Separations. Anal Chem. 2006, 78, 3947-3950.
4. Eiji Yashima. Polysaccharide-based chiral stationary phases for high-performance liquid chromatographic enantioseparation. J Chromatogr A. 2001, 906, 105–125.
5. Gao S, Zhang C H, Yu L M. Optical resolution of rosiglitazone and pioglitazone by high-performance liquid chromatography using chiral stationary phase. Fenxi Ceshi Xuebao. 2009, 28(9), 1088-1091.
6. Babak Jamal, Inga Bjornsdottir, Ole Nordfang. Steen Honor Hansen.; Investigation of racemisation of the enantiomers of glitazone drug compounds at different pH using chiral HPLC and chiral CE. J Pharm Biomed Anal. 2008, 46, 82–87.
7. Venugopal Sriram, Kalpana Sriram, Jagadishbabu Angirekula, Upendra M Tripathi, Devanna Nayakanti. Development and validation of stability indicating reverse phase HPLC method for the determination of impurities in pioglitazone hydrochloride. Int J Pharm Biomed Sci. 2012, 3(3), 89-96.
8. Chaitanya Krishna A, Chelladurai R, Rajaram S Patil. A simple and rapid method to determine pioglitazone from human plasma by liquid chromatography tandem mass spectrometry. Int Res J Pharm Sci. 2012, 3(1), 19-23.
9. Farnoush Faridbod, Mohammad Reza Ganjali, Ensieh Nasli-Esfahani, Bagher Larijani, Siavash Riahi, Parviz Norouzi. Potentiometric sensor for quantitative analysis of pioglitazone hydrochloride in tablets based on theoretical studies. Int J Electrochem Sci. 2010, 5, 880 – 894.
10. Sayed S, Thomas A, Kotapali L. RP-HPLC method development for determination of pioglitazone hydrochloride from tablets. J Pharm Res. 2009, 2(9), 1479-1480.
11. Saranjith Singh, Monical Bakshi. Development of validated stability-indicating assay methods-critical review. J Pharm Biomed Anal. 2002, 28, 1011.
12. ICH, Q1A. Stability Testing of New Drug Substances and Products. International Conference on Harmonization, IFPMA, Geneva, 1993.
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How to Cite
Gowramma, B., and S. Meyyanathan. “STABILITY INDICATING CHIRAL HPLC METHOD FOR THE ESTIMATION OF PIOGLITAZONE ENANTIOMERS IN PHARMACEUTICAL FORMULATION”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 8, no. 5, Sept. 2015, pp. 63-66, https://innovareacademics.in/journals/index.php/ajpcr/article/view/5071.
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Original Article(s)