Abstract
A simple, accurate, precise and economical Q- Absorption Ratio spectrophotometric method was developed and validated for estimation of Anagliptin and Metformin HCl in synthetic mixture. Anagliptin and Metformin HCl showed an iso-absorptive point at 238 nm in distilled water. The second wavelength used was 233 nm which is λmax of Metformin HCl in distilled water. The concentration of the drugs was determined by using ratio of absorbance at iso-absorptive point (λ1 = 238 nm) and at the λmax of Metformin HCl (λ2 = 233 nm). This method is linear for both drugs; in range of 2–12 μg/mL at λ1 (R2 = 0.999) and at λ2 (R2 = 0.9998) for Anagliptin, and in the range of 5–30 μg/mL for Metformin HCl found at λ1 (R2 = 0.9995) and at λ2 (R2 = 0.9997). The % Recovery was 100.42–101.83 % of Anagliptin and 99.94–101.63 % of Metformin HCl by standard addition method. The LOD was found to be 0.201 μg/mL and 0.262 μg/mL for Anagliptin at λ1 and λ2 respectively. The LOD was found to be 0.320 μg/mL and 0.167 μg/mL for Metformin HCl at λ1 and λ2 respectively. The LOQ was found to be 0.610 μg/mL and 0.794 μg/mL for Anagliptin at λ1 and λ2 respectively. The LOQ was found to be 0.972 μg/mL and 0.506 μg/mL for Metformin HCl at λ1 and λ2 respectively. The method was found to be precise as % RSD was less than 2.00 in Repeatability, Interday and Intraday precision for Anagliptin and Metformin HCl. The % assay of analyte drugs in synthetic mixture was found to be 100.601% of Anagliptin and 100.206 % of Metformin HCl which showed good applicability of the developed method.
Highlights
Anagliptin, in form of Suiny® (100 mg tablets) is new drug formulation for type 2 diabetes therapy approved by the Japanese regulatory authority in 2014 [1]
Anagliptin, chemically N-[2-[[2-[(2S)-2-Cyanopyrrolodin-1-yl]-2-oxoethyl] amino]-2-methylpropyl]-2-methylpyrazolo [1, 5-a] pyrimidine-6-carboxamide (Figure 1) is a Dipeptidyl Peptidase 4 (DPP 4) inhibitor which is used in treatment of type 2 NIDDM [2]
Dipeptidyl Peptidase 4 enzyme breaks down the incretins GLP-1 gastrointestinal hormones released in response to a meal
Summary
Anagliptin, in form of Suiny® (100 mg tablets) is new drug formulation for type 2 diabetes therapy approved by the Japanese regulatory authority in 2014 [1]. Anagliptin, chemically N-[2-[[2-[(2S)-2-Cyanopyrrolodin-1-yl]-2-oxoethyl] amino]-2-methylpropyl]-2-methylpyrazolo [1, 5-a] pyrimidine-6-carboxamide (Figure 1) is a Dipeptidyl Peptidase 4 (DPP 4) inhibitor which is used in treatment of type 2 NIDDM [2]. By preventing GLP-1 inactivation, they are able to increase the secretion of insulin and suppress the release of glucagon by the alpha cells of the pancreas. This drives blood glucose levels towards normal level [3, 4]. This drug is not official in any of the pharmacopeia. A literature survey revealed that few methods are reported for determination of ANA, either alone or in combination [6], by spectrophotometric [7, 8, 9], HPLC [10], LC/MS [11]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.