Novel RP-HPLC method development and validation for simultaneous estimation of metformin, voglibose and pioglitazone in bulk and triple fixed drug combinations pharmaceutical dosage form
Reducing treatment complexity can be achieved through the use of single-tablet triple fixed-dose combinations of oral hypoglycemic agents. A simple, precise and accurate reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of Metformin (MET), Voglibose (VOG) and Pioglitazone (PIO) in pharmaceutical dosage forms. Chromatographic separation was achieved on an Younglin (SK) gradient System with UV 730 D detector and Cosmosil C18 (250 x 4.6 mm, 5μm) column, maintained at 45°C using 0.1% v/v acetonitrile: triethylamine (30:70, v/v), pH 2.5 with flow rate 0.8 ml/min with injection volume at 20 μl and wavelength ultraviolet detection at 232 nm. MET, PIO and VOG obey Beer–Lambert’s law over the concentration range of 200-600 µg/ml, 30-90 µg/ml and 0.08-0.24 µg/ml, respectively, with regression equations y=2.021x -186.7 (MET) (R2 = 0.998), y=9.876x-202.31 (PIO) (R2 = 0.999), and y= 502.3x-17.23 (VOG) (R2 = 0.999). % RSD and recoveries were 100.57-101.60 for MET, 99.79-102.61 for PIO and 100.02-101.05 for VOG indicate good accuracy of method. The marketed formulation analyzed using developed method and mean % amount were found 101.62, 100.38 and 98.75 for MET, PIO and VOG respectively with % RSD values NMT 2.0%. The developed spectrophotometric method can be employed for routine analysis of MET, VOG and PIO in bulk and tablet formulation. The developed RP-HPLC method was sensitive and selective for estimation of metformin, voglibose and pioglitazone in combined dosage form. The method was validated as per ICH guidelines.
Keywords: RP-HPLC, ICH guidelines, Metformin, Voglibose, Pioglitazone, Validation
2. Meshram DM, Langade DG, Kinagi SB, Naikwadi AA, Morye V, Chopra D. Evaluation of efficacy and safety of fixed dose combination of glimepiride 2 mg pluspioglitazone 15 mg plus metformin SR 500 mg in the management of patients with type-2 diabetes mellitus. Journal of the Indian Medical Association, 2005; 103(8):447-50.
3. Rao C, Faruqui AA. Efficacy and safety of oral triple drug combination (voglibose, glimepiride and metformin) in the management of type 2 diabetes mellitus. Int J Curr Res Rev, 2013; 5:20-6.
4. Jain D, Jain S. Amin M. Simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride and glimepiride by RP-HPLC in tablet formulation. J Chromatogr Sci, 2008; 46(6):50-504.
5. Kadam VN, Yadav PJ, Mohite SK, Magdum CS. Development and validation of analytical methods for simultaneous estimation of voglibose, glimepiride and metformin hydrochloride in bulk and tablet dosage form by HPLC. Ijppr.Human, 2014; 1(2)10-21.
6. Skoog DA, Holler FJ, Nieman TA, Principal of Instrumental Analysis, 5th edition, Thomson Brook, 2005: 674-696.
7. Lakshmi KS, Rajesh T, Sharma S. Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms. Int J Pharm Sci, 2009; 1(2):162-6.
8. Sonia K, Babu PK. RP-HPLC analysis of metformin hydrochloride and voglibose and study of its different analytical parameter. Int J Pharm Sci Res, 2013; 1(4):1469-74.
9. Sujana K et al. Simultaneous estimation of pioglitazone hydrochloride and metformin hydrochloride using UV spectroscopic method. J Biomed Sci Res, 2010; 2(2):110-5.
10. Neha R, Manjula B, Prachi K, Ritu K. Simultaneous quantification of voglibose and metformin by validated analytical method in tablet dosage form. IJPT, 2011; 3(2):53-6.
11. ICH. Topic Q2 (R1) Validation of analytical procedures: Text and methodology, note for guidance on validation of analytical procedures: text and methodology. 1995. (CPMP/ICH/381/95).
12. International Conference on Harmonization. Draft guidance on specifications: Test procedures and acceptance criteria for new drug substances and products: chemical substances, Federal Register (notices) 2000; 65(251):83041-83063.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (SeeÂ The Effect of Open Access).