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Estimation of Anagliptin and Metformin HCI in Bulk

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Estimation of Anagliptin and Metformin HCI in Bulk AEGAEUM JOURNAL ISSN NO: 0776-3808 “ESTIMATION OF ANAGLIPTIN AND METFORMIN HCl IN BULK & PHARMACEUTICAL DOSAGE FORM USING STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY” Ruchi H. Majithia*1 & Dr. Akruti Khodadiya2 *Assistant Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat- 380060 1Research Scholar, C. U. Shah College of Pharmacy and Research, Gujarat- 363030 1Mail ID: [email protected] 1Mobile No: +91-8155921801 2Associate Professor, C.U. Shah University, Wadhwan city, Gujarat- 363030 2Mail ID: [email protected] *Corresponding author Volume 8, Issue 7, 2020 http://aegaeum.com/ Page No: 46 AEGAEUM JOURNAL ISSN NO: 0776-3808 ABSTRACT: A simple, accurate and precise stability indicating high performance liquid chromatography was developed and validated for estimation of Anagliptin and Metformin HCl in bulk and pharmaceutical dosage form. The mobile phase Potassium Dihydrogen Phosphate Buffer (pH 2.7): Acetonitrile solution in the ratio of (15:85% V/V) at detection wavelength 243 nm for Anagliptin and Metformin and flow rate 2 mL/min and the retention time for Anagliptin and Metformin HCl was found to be 11.23 and 6.02 respectively. The method was linear over the concentration ranges 10-60 μg/mL for Anagliptin and 25-150 μg/mL for Metformin. The LOD was 1.158 μg/mL for Anagliptin and 2.344 μg/mL for Metformin. The LOQ was 3.508 μg/mL for Anagliptin and 7.102 μg/mL for Metformin. During stress conditions, ANA degraded significantly under acidic, alkaline, oxidative and thermal stress conditions; degraded moderately under photolytic stress conditions; and showed negligible degradation under elevated temperature and humidity conditions. MET degraded significantly under acidic, alkaline and oxidative stress conditions; degraded moderately under thermal and humidity stress conditions and showed negligible degradation under photolytic stress condition. KEYWORDS: Anagliptin (ANA), Metformin HCl (MET), High Performance/ Pressure Liquid Chromatography(HPLC), Simultaneous estimation. INTRODUCTION Anagliptin is used for type 2 diabetus mellitus and longer duration of action for treatment of type 2 non-insulin dependent diabetus mellitus disease as a Dipeptidyl Peptidase 4 inhibitor 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 [01]. Dipeptidyl Peptidase 4 enzyme breaks down the incretins GLP-1 gastrointestinal hormones released in response to a meal. 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 [02-03]. This drug is not official in any of the pharmacopeia. Anagliptin is a very effective pill with minimum risk profile for type 2 diabetus mellitus and longer duration of action for treatment of type 2 non- insulin dependent diabetus mellitus disease [04]. A literature survey revealed that few methods are reported for determination of ANA, either alone or in combination, by spectrophotometric [05-07], HPLC [08-09], LC/MS [10]. Volume 8, Issue 7, 2020 http://aegaeum.com/ Page No: 47 AEGAEUM JOURNAL ISSN NO: 0776-3808 Figure 1: Chemical Structure of Anagliptin .HCl Figure 2: Chemical structure of Metformin HCl Metformin is chemically a 1-Caramimidamido-N, N-Dimethylmethanimidamide [11] (Figure 2) and has pharmacological action based on Biguanides category [12-13]. It suppresses hepatic gluconeogenesis and glucose output from liver. This is the major action responsible for lowering blood glucose in diabetics. It is official in IP [14], BP [15], and USP [16]. Literature review revels that many spectrophotometric [17-18], HPLC [19-20], HPTLC [21] methods are reported for determination of Metformin hydrochloride (HCl), either alone or in combination[08]. The aim of the present work was to develop a stability indicating HPLC method for simultaneous estimation of ANA and MET in bulk and pharmaceutical dosage form. It is pertinent to note that, some of the published methods enabled estimation of drugs in combination products containing two drugs via spectrophotometric. However, so far, not any HPLC method was reported in pharmaceutical dosage form. Hence, HPLC chromatographic conditions were developed with forced degradation studies and the method was validated to establish selectivity with respect to excipients and degradation products. MATERIALS AND METHOD: Apparatus Chromatographic separation of drugs was performed on a Shimadzu HPLC instrument (LC_2010 CHT) [software LC Solution, equipped with photo diode array detector (SPD- Volume 8, Issue 7, 2020 http://aegaeum.com/ Page No: 48 AEGAEUM JOURNAL ISSN NO: 0776-3808 M20A), Auto-sampler]. The system contains a quaternary gradient pump, auto sampler, column oven and a PDA detector. Software referred to above was used to record and integrates the chromatograms. Among other instruments, analytical balance (Acculab ALC- 210.4, Huntingdon Valley, PA), Photostability chamber (TH-90S, Thermolab, Mumbai, India) , Hot air oven (TO-90S, Thermolab), pH meter (Thermo Electron Crop., Pune, India), Sonicator (EN 30 US, Enertech Fast Clean, Mumbai, India) were also used at different stages of development and validation of stability indicating assay method. Chemicals and Reagents The API of Anagliptin and Metfromin procured from Intas Pharmaceuticals LTD, Ahmedabad. Combination test product METOANA Tablets 100/250 mg (manufactured by Sanwa Kagaku Kenkyusho Co. LTD) was procured from the market. All the solvents like Methanol, Acetonitrile, Phosphate Buffer and Potassium dihydrogen phosphate were of HPLC grade from Finar Chemicals Ltd, Ahmedabad, India. All the chemical reagents were of analytical grade. Preparation of Standard Stock Solution The standard solution was prepared by weighing accurately about 10 mg of ANA and 25 mg of MET transferred into clean and dry 10 mL volumetric flask. Initially about 5 mL methanol was added to the flask respectively and sonicated. The volume was made up to the mark with the methanol to achieve 1000 µg/mL of ANA and 2500 µg/mL of MET standard stock solutions. Preparation of working standard solution From the above prepared Stock solutions, pipette out 1 mL of ANA and 1 mL MET solution and transferred into a clean and dry 10 mL volumetric flask, methanol was added upto the mark to get final concentration 100 µg/mL & 250 µg/mL respectively, in mixture. Preparation of test solution Twenty METOANA tablets were accurately weighed, their average weight was calculated. Amount of finely powdered tablet equivalent to 100 mg ANA and 250 mg MET was weighed and transferred into a 100 mL volumetric flask and the volume was adjusted to mark with methanol. The contents of the flask were sonicated for 30 min to dissolve the active ingredients completely. The solution was filtered through a Whatman filter paper no. 41. Volume 8, Issue 7, 2020 http://aegaeum.com/ Page No: 49 AEGAEUM JOURNAL ISSN NO: 0776-3808 From this 1 mL aliquot was transferred into a 100 mL volumetric flask and the volume was made with methanol. This corresponds to 10 µg/ mL of ANA & 25 µg/ mL MET, in mixture was analyzed for assay determination. Standardized Chromatographic conditions The analyte drugs and degradation products were well separated with ZORBAX RX C8 (250 mm × 4.6 mm, 5 µm) as a stationary phase and gradient system of Potassium Dihydrogen Phosphate Buffer (pH 2.7): Acetonitrile solution in the ratio of (15:85% V/V). The flow rate was adjusted to 2 mL/min. Determination was done at wavelength 243 nm. Column temperature was set to 300 C. Total run time was 20 min. Injection volume was 10 µL. Methanol was used as a diluent. METHOD VALIDATION The proposed method was validated as per ICH guidelines Q2 R1 [22]. System suitability test parameters System suitability tests are used to verify that the resolution and repeatability of the system were adequate for the analysis intended. The parameters used in this test were the chromatographic peak resolution (>2), theoretical plate number (>2000) and tailing factor (<1.8). The repeatability of these parameters was checked by injecting six solutions of ANA and MET. Linearity From the standard stock solution containing 100 µg/mL ANA and 250 µg/mL MET, aliquots of 1 mL, 2 mL, 3 mL, 4 mL, 5 mL and 6 mL were transferred in clean and dry 10 mL volumetric flasks respectively. The volume was made up to the mark with diluent. This yielded solution of 10, 20, 30, 40, 50 and 60 µg/mL of ANA and; 25, 50, 75, 100, 125 and 150 µg/mL of MET respectively. An injection volume of 10 μL of each solution was injected under operating chromatographic condition. Six replicates of each concentration were performed and then calibration plots were determined by linear least – squares regression. The plate was developed on previously described mobile phase. The peak areas were plotted against the corresponding concentrations to obtain the calibration graphs. Precision Repeatability was determined by applying six replicates of test solution (10 µg/mL ANA and 25 µg/mL MET). The intraday and interday precisions were determined by responses of six Volume 8, Issue 7, 2020 http://aegaeum.com/ Page No: 50 AEGAEUM JOURNAL ISSN NO: 0776-3808 replicates on same and different days for the test concentration. The results were reported in terms of % RSD. Accuracy Recovery study was carried out by standard addition method where known amount of standard concentration at 50%, 100% and 150% of the test solution were spiked in the test solution in triplicate. The amount of drugs was estimated by substituting values in regression equation. The % RSD of the recovery was calculated. LOD and LOQ The LOD and LOQ of the developed method were calculated from the calibration curve using equations, LOD = 3.3 ×ϭ/S and LOQ = 10 × ϭ/S where ϭ is the standard deviation of y- intercept and S is the slope of the curve.
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