DEVELOPMENT AND VALIDATION STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF VILDAGLIPTIN AND METFORMIN HYDROCHLORIDE IN THE PHARMACEUTICAL DOSAGE FORMS


Atul R. Bendale, R. P. Singh, G. Vidyasagar

Abstract


Objective: A simple, precise, and accurate stability indicating high-performance thin layer chromatography method was developed and validated of vildagliptin (VIL) and metformin (MET) in pharmaceutical dosage forms.

Methods: In the present study, system suitability test, stress study, alkali hydrolysis, acid hydrolysis, neutral hydrolysis, oxidative stress degradation, dry heat degradation, wet heat degradation, photodegradation study has been used. In this method, optimization by changing various parameters, such as organic solvent and the composition of the mobile phase, acid or base modifier used in the mobile phase; by varying one parameter and keeping all other conditions constant. 10 µl of the stock solution for MET (500 ng/band) and 2 µl of the stock solution for VIL (100 ng/band) were applied to TLC plates. The final solutions were applied on the HPTLC plates and these were developed as per the optimized densitometry conditions.

Results: From the spectra, it was observed that MET and VIL exhibited good absorbance at about 217 nm. Both the drugs showed degradation with additional peaks at Rfvalues of 0.16 for MET and with Rfvalues 0.81 for VIL respectively. The method was validated for linearity, precision, accuracy, limit of detection, limit of quantification, ruggedness, specificity, and robustness. Good separation was achieved by using the mobile phase Hexane: Methanol: Acetonitrile: Glacial Acetic Acid (2:3.5:2.5:0.2 v/v/v/v) with retardation factor (Rf) values of 0.22±0.01 for MET and 0.73±0.02 for VIL.

Conclusion: A validated HPTLC method was developed for the determination of metformin hydrochloride and vildagliptin. The method is simple, quick, and can be applied routinely for the analysis of these drugs from marketed dosage forms.


Keywords


Metformin hydrochloride, Vildagliptin, Method validation, HPTLC

| PDF | HTML |

References


Havele S, Dhaneshwar S. Development and validation of a HPLC method for the determination of metformin hydrochloride, gliclazide and piogliglitazone hydrochloride in multicomponent formulation. Webmed Central Pharm Sci 2010;1:WMC001078.

Gopal NM, Sridhar C. A validated stability indicating a ultra-performance liquid chromatographic method for simultaneous determination of metformin hydrochloride and empagliflozin in bulk drug and tablet dosage form. Int J Appl Pharm 2017;9:45-50.

Kumar P, Vasudevan R, Deecaraman. A validated RP-HPLC method for simultaneous estimation of metformin and saxagliptin in tablets. Rasayan J Chem 2012;5:137-41.

Jayaprakash R, Natesan SK. Stability indicating RP-HPLC method development and validation for the simultaneous determination of vildagliptin and metformin in pharmaceutical dosage form. Int J Pharm Pharm Sci 2017;9:150-7.

Barden AT, Salamon B, Schapoval EE, Steppe M. Stability-indicating RP-LC method for the determination of vildagliptin and mass spectrometry detection for a main degradation product. J Chromatogr Sci 2012;50:426-32.

Shaw RJ, Lamia KA, Vasquez D. The kinase LKB1 mediates glucose homeostasis in liver and therapeutic effects of metformin. Science 2005;310:1642-6.

El-Mir MY, Nogueira V, Fontaine E. Dimethyl biguanide inhibits cell respiration via an indirect effect targeted on the respiratory chain complex I. J Biol Chem 2000;275:223-8.

Rojas LB, Gomes MB. Metformin: an old but still the best treatment for type 2 diabetes. Diabetol Metab Syndr 2013;5:6.

Alam I, Jat RK, Singh R, Srivastava V, Srivastva S. Development and validation of reverse phased phase HPLC method for estmation ondansetron hydrochloride in bulk drug. Int Res J Pharm 2012;3:111-3.

Albert R, Horwitz W. Validation of analytical procedure. Anal Chem 1997;69:789-90.

Amin N, Seth A. Development and validation of stability indicating assay method for LNC and tramadol in tab. Dosage form by RP-HPLC, Pharma Science Monitor. Int J Pharm Sci 2012;3:11-29.

Woolf AD, Pfleger B. Burden of major musculoskeletal conditions, theme papers. Bull World Health Organization 2003;81:646-56.

Beckett A. In practical pharmaceutical chemistry. Part II. CBS Pubmethers and Distributors; 1997. p. 275-337.

Bhatt P. Development and validation of stability indicating RP-HPLC method for LNC in bulk drug. Int J Res Pharm Biomed Sci 2013;4:959-66.

Bhavsar S. Validated RP-HPLC method for simultaneous estimation of LNC and THC in solid dosage form. J Chem Pharm Res 2010;2:563-72.

Bhusari V. Development of validated stability-indicating HPLC assay method for DKP. Int J Pharm Pharm Sci 2012;4:321-6.

Chaudhari BG, Trivedi JB. Simultaneous spectrophotometric estimation of THC and DKP in pharmaceutical dosage form. Int J Biomed Adv Res 2012;3:179-83.

Chitlange S. Simultaneous estimation of THC and aceclofenac in pharmaceutical dosage form by spectrophotometric and LC method. Der Pharm Lett 2010;2:86-93.

Choudhari V, Kuchekar B. Simultaneous spectrophotometric estimation of LNC and THC in combined dosage form. Res J Pharm Tech 2013;3:807-11.

Damodiya V, Singh R, Jat RK, Chokshi R. Method development and validation of terbinafine HCl in cream by RP-HPLC. Inventi Impact: Pharm Anal Qual Assur 2012;307:12.

Dhaneshwar S. Validated HPTLC method for simultaneous estimation of THC and aceclofenac in bulk drug and formulation. Int J Pharm Bio Sci 2011;2:482-90.

Goyal N, Bhandari A, Jain S, Patel R. Method development and validation of etoricoxib and THC in combined pharmaceutical solid dosage form by RP-HPLC method. Int J Pharm Studies Res 2011;2:106-9.




About this article

Title

DEVELOPMENT AND VALIDATION STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF VILDAGLIPTIN AND METFORMIN HYDROCHLORIDE IN THE PHARMACEUTICAL DOSAGE FORMS

Keywords

Metformin hydrochloride, Vildagliptin, Method validation, HPTLC

DOI

10.22159/ijap.2018v10i1.20555

Date

06-01-2018

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 10, Issue 1 (Jan-Feb), 2018 Page: 36-45

Online ISSN

0975-7058

Authors & Affiliations

Atul R. Bendale
Dept. of Pharmaceutical Sciences, Suresh Gyan Vihar University, Jaipur, Rajasthan

R. P. Singh
Dept. of Pharmaceutical Sciences, Suresh Gyan Vihar University, Jaipur, Rajasthan
India

G. Vidyasagar
Pharmacy Department, Kutch University, Bhuj, Gujarat
India


Refbacks

  • There are currently no refbacks.