RP-HPLC Estimation of Alogliptin and Pioglitazone Simultaneously in Combined Tablet Dosage Forms

Year 2017, Volume: 21 Issue: 2, 345 - 354, 01.04.2017

B Haribabu P. Rama Krishna Veni K. Bala Murali Krishna K. Lakshmi Prameela

https://doi.org/10.12991/marupj.300864

Abstract

A high performance liquid chromatographic method

was developed to quantify alogliptin and pioglitazone

simultaneously in bulk and combined tablet dosage form. The

chromatographic analysis was done on a Zorbax C8 column

(150 mm x 4.6 mm internal diameter, 5 μm particle size) with

a mobile phase of 0.1 M ammonium acetate and methanol

(50:50, v/v) at 1.0 mL/min. The effluents were monitored at

248 nm and the retention time of alogliptin and pioglitazone

were 2.883 min and 4.329 min, respectively. Calibration

curves were linear from 6.25-18.75 μg/mL for alogliptin and

11.25-33.75 μg/mL for pioglitazone. The LOD and LOQ

values for alogliptin were 0.047 and 0.157 μg/mL, respectively;

corresponding values for pioglitazone were 0.085 and 0.284 μg/

mL, respectively. The precision for alogliptin and pioglitazone

was in the range of 0.094-0.303% and 0.072-0.239%,

respectively, with corresponding accuracy of 99.450-99.692%

and 100.184-100.422%. The developed and validated method

was successfully applied for the simultaneous determination

of alogliptin and pioglitazone in tablet formulation.

Keywords: Alogliptin, Pioglitazone, Liquid Chromatography,

Keywords

Alogliptin, Pioglitazone, Liquid Chromatography, Tablets, Assay

Algoliptin ve Pioglitazon’un kombine tablet dozaj formunda RP-HPLC yöntemiyle eş zamanlı miktar tayini

Abstract

Algoliptin ve pioglitazon’un bulk üründe ve kombine tablet

dozaj formunda eş zamanlı miktar tayini için bir yüksek basınçlı

sıvı kromatografisi (HPLC) yöntemi geliştirildi. Geliştirilen

yöntemde; stasyoner faz olarak Zorbax C8 kolon (150 mm

x 4.6 mm, partikül büyüklüğü:5 μm), mobil faz olarak 0.1 M

amonyum asetat tamponu and metanol (50:50, h/h) kullanıldı

ve mobil fazın akış hızı 1.0 mL/min olarak belirlendi. Alogliptin

ve pioglitazon’un, 248 nm’de, alıkonma zamanları sırasıyla 2.883

ve 4.329 dakika olarak belirlendi. Alogliptin ve pioglitazon

için kalibrasyon eğrileri sırasıyla 6.25-18.75 μg/mL ve 11.25-

33.75 μg/mL aralığında doğrusal olarak belirlendi. Alogliptin

için LOD ve LOQ değerleri 0.047 and 0.157 μg/mL olarak

belirlenirken, pioglitazon’un LOD ve LOQ değerleri 0.085 and

0.284 μg/mL olarak tespit edildi. Alogliptin ve pioglitazon için

kesinlik değerleri sırasıyla % 0.094-0.303 ve % 0.072-0.239

aralığında ve doğruluk değerleri %99.450-99.692 ve %100.184-

100.422’ye karşılık gelecek şekilde belirlendi. Geliştirilen ve

valide edilen yöntem, algoliptin ve pioglitazon’un tablette eş

zamanlı miktar tayini için başarıyla uygulanabilir bir yöntemdir.

Keywords

Alogliptin, Pioglitazon, Sıvı kromatografisi, Tablet, Yöntem geliştirme ve validayon

References

• 1. Jarvis CI, Cabrera A, Charron D. Alogliptin: a new dipeptidylpeptidase-4 inhibitor for type 2 diabetes mellitus. AnnPharmacother 2013; 47: 1532-9.
• 2. Marino AB, Cole SW. Alogliptin: safety, efficacy and clinicalimplications. J Pharm Pract 2015; 28: 99-106.
• 3. Golightly LK, Drayna CC, McDermott MT. Comparativeclinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors.Clin Pharmacokinet 2012; 51: 501-14.
• 4. Cyrus VD, Vijay S. Pioglitazone in the Treatment of Type2 Diabetes: Safety and Efficacy Review. Clin Med InsightsEndocrinol Diabetes 2010; 3: 43-51.
• 5. Brunetti L, Kalabalık J. Management of Type-2 diabetesmellitus in adults. Focus on individualizing non-insulintherapies. P & T 2012; 37: 687-96.
• 6. van Raalte DH, van Genugten RE, Eliasson B, Moller-GoedeDL, Mari A, Tura A, Wilson C, Fleck P, Taskinen MR, SmithU, Diamant M. The effect of alogliptin and pioglitazonecombination therapy on various aspects of β-cell function inpatients with recent-onset type 2 diabetes. Eur J Endocrinol2014; 170: 565-74.
• 7. Julio R, Silvio EI, Jochen S, Penny RF, Craig AW, Qais M.Initial combination therapy with alogliptin and pioglitazonein drug-naive patients with type 2 diabetes. Diabetes Care2010; 33: 2406-8.
• 8. ht t p : / / www. fd a . gov / Ne wsEv e nt s / Ne w s ro om/PressAnnouncements/ucm336942.htm
• 9. Raval K, Srinivasa U. First order derivative and dualwavelength spectrophotometry methods development andvalidation for simultaneous estimation. Int J Pharm PharmaSci 2014; 6: 730-8.
• 10. Anusha M, Manzoor A, Satishkumar SA, Vijaya KCA.Simultaneous estimation of alogliptin and piogliazone in bulkand combined tablet dosage form by UV-spectrophotometricmethods. Int J Uni Pharma Bio Sci 2014; 3: 363-76.
• 11. Komal S, Amrita P. Development and validation of HPTLCmethod for simultaneous estimation of alogliptin benzoateand pioglitazone hydrochloride in bulk drugs and combineddosage forms. Int J Pharma Res Rev 2015; 4: 35-42.
• 12. Raval K, Srinivasa U. Development and validation of HPLCmethod for the simultaneous estimation of pioglitazone andalogliptin in bulk and dosage form. Int J Cur Res 2014; 6:10201-7.
• 13. Neelima B, Kumar PR, Bindu VH, Prasad YR. A validatedstability indicating RP-HPLC method for simultaneousdetermination of alogliptine and pioglitazone in bulk andpharmaceutical formulations. Int J Pharm 2014; 4: 458-64.
• 14. Manzoor A, Anusha M, Satishkumar SA, Kuppast IJ,Siddalingaswamy MS, Ravi MC. RP-HPLC methoddevelopment and validation for simultaneous estimation ofalogliptin and pioglitazone in combined tablet dosage form.World J Pharm Pharm Sci 2015; 4: 863-74.
• 15. Mokhtar MM, Sherin FH, Fotouh RM, Mona MA.Development and validation of a reversed phase HPLCmethod for simultaneous determination of antidiabetic drugsalogliptin benzoate and pioglitazone HCl. Der PharmaciaSinica 2016; 7: 32-40.
• 16. International Conference on Harmonization, Validationof Analytical Procedure, Text and Methododlogy Q2 (R1),IFMA, Geneva, Switzerland, 2005.