Research Article
Year 2017,
Volume: 21 Issue: 2, 345 - 354, 01.04.2017
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,
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.
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.
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.
There are 16 citations in total.
Details
| Subjects | Health Care Administration |
|---|---|
| Journal Section | Articles |
| Authors | |
| Publication Date | April 1, 2017 |
| Published in Issue | Year 2017 Volume: 21 Issue: 2 |
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