DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF VOGLIBOSE IN PHARMACEUTICAL DOSAGE FORMS
Keywords:
Voglibose, HPTLC, Densitometric estimation, Method development, ValidationAbstract
Objective: This paper describes a new, simple, precise, accurate and specific HPTLC method for estimation of voglibose as a bulk drug and in tablet dosage forms.
Methods: Chromatographic separation of the drug was performed on aluminum plates pre-coated with silica gel 60 F254 as the stationary phase and a mobile phase comprising of toluene: ethyl acetate: methanol: 30% ammonia 5:4:1.5:0.2 (v/v/v/v). Densitometric quantification of voglibose was carried out at 292 nm. Voglibose was detected satisfactorily with a Rf value 0.26.
Results: The accuracy and reliability of the method was assessed by evaluation of linearity (0.2-1.2 µg/spot), precision (intra-day RSD 0.6-0.9% and inter-day RSD 0.20-0.25%), accuracy (97.32-102.46%) and specificity according to ICH guidelines.
Conclusion: The proposed HPTLC method is less expensive, simpler, rapid and more flexible than the reported RP-HPLC method for routine analysis of voglibose in bulk and tablet dosage forms.
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References
Chatwal GR, Aanad SK. Instrumental methods of chemical analysis. 5th ed. Mumbai: Himalaya Publishing House; 2002.
Beckett AH, Stenlake JB. Practical pharmaceutical chemistry. 4th ed. Part 2, New Delhi: CBS Publishers and Distributers; 2001. p. 116-67.
Maryadele JO, The Merck Index: An encyclopedia of chemicals drugs and biologicals, Merck Research Laboratories, Division of Merck Co, Inc, Whitehouse Station, Neil (Eds), New Jersey; 2006.
Maryadele J, Heckelaman PE, Koch CB, The Merck Index: An encyclopedia of chemicals. 14th ed. Drugs and Biologicals. Merk Research Laboratories, USA; 2006.
Shubhangi CD, Sanjay GW, Mahendra CB. Stability indicating RP-HPLC method for estimation of voglibose in bulk and tablet dosage form. Pharmacophore 2013;4(5):158-65.
Patel SA, Patel NJ. Development and validation of HPLC method for estimation of voglibose in bulk and tablets. J Pharm Educ Res 2011;2(2):78-83.
Chepurwar SB, Shirkhedkar AA, Bari SB. Development and validation of HPLC method for estimation of voglibose in bulk and tablets. J Chromatogr Sci 2007;45:531-6.
Udhan RR, Jaybhaye S, Pathan IB. Development and validation of a simple UV spectrophotometric method for the determination of desloratadine both in bulk and marketed dosage formulation. Int J Pharm Res Sci 2013;1(1):33-6.
Bhagyalakshami RM, Ravi TK. Development and validation of UV-spectroscopic method for estimation of voglibose in bulk and tablets. J Chem Pharm Res 2010;2(2):350-6.
Neelima K, Rajendra PY. Analytical method development and validation of metformin hydrochloride, voglibose, glimepiride in bulk and combined tablet dosage form by gradient RP-HPLC. Pharm Methods 2014;5(1):27-33.
ICH Harmonized Tripartite Guidelines, Validation of analytical procedure: Text and methodology' Q2 (R1); 2005.
ICH. Q2B Validation of analytical procedure: Methodology. International conference on harmonization, Geneva; 1996.
ICH Harmonized Tripartite Guideline, Validation of analytical procedure: Methodology (Q2B); 1996.