Simultaneous Estimation of Sacubitril and Valsartan Combination of Drug in Tablet Dosage Form Using Hydrotropy by UV Spectrophotometry

Sacubitril/valsartan, traded under the brand name Entresto between others, is a fixed-dose combination medication for use heart failure. Sacubitril is a neprilysin inhibitor (A prodrug) and is used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure. It is anti - hypertensive drug. Valsartan is an Angiotensin Receptor Blocker (ARB) that may be used to treat a variety of cardiac conditions including hypertension, diabetic nephropathy and heart failure. Two UV-spectrophotometric methods have been developed and validated for simultaneous estimation of Sacubitril and Valsartan in a tablet dosage form. The first method employed solving of simultaneous equations based on the measurement of absorbance at two wavelengths, 226.0 nm and 254.0 nm, 𝜆max for Sacubitril and Valsartan, respectively. The second method was absorbance ratio method, which involves formation of Q-absorbance equation at 240 nm (isoabsorptive point) and also at 254 nm (𝜆max of Valsartan). The methods were found to be linear between the range of 4-12 𝜇g/mL for Sacubitril and 2-10 𝜇g/mL for Valsartan using Methanol as solvent. The mean percentage recovery was found to be 96.68%and 101.89% for the simultaneous equation method and 100.2% and 104.53% for the absorbance ratio method, for sacubitril and valsartan respectively. It could be concluded from the results obtained in the present investigation that the two methods for simultaneous estimation of sacubitril and valsartan in tablet dosage form are simple, rapid, accurate, precise and economical and can be used, successfully, in the quality control of pharmaceutical formulations and other routine laboratory analysis. The reviewed highlights various analytical techniques such as high-performance liquid chromatography (HPLC), ultra- performance liquid chromatography (UPLC), UV Spectroscopy, high per-formance thin layer chromatography (HPTLC), liquid chromatography coupled to tandem mass spectrometry (LC- MS), RP-HPLC and other chromatographic method used. The combination of these drugs with different method was examine and the commonly use of the drugs in hypertensive.

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Q-Absorbance Ratio Spectrophotometric Method for the Simultaneous Estimation of Metformin Hydrochloride and Voglibose in Tablet Dosage form

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.00554 ◽

2021 ◽

pp. 3179-3183

Author(s):

Kedar Tejashree R. ◽

A.R. Dashetwar ◽

D.P. Kardile ◽

A.P. Jadhav ◽

V.C. Bhagat ◽

...

Keyword(s):

Spectrophotometric Method ◽

Dosage Form ◽

Ratio Method ◽

Metformin Hydrochloride ◽

Simultaneous Estimation ◽

Absorbance Ratio ◽

Ich Guidelines ◽

Highly Sensitive ◽

Stock Solutions ◽

Tablet Dosage

A new, simple, accurate, precise and reproducible UV-Spectrophotometric method is being developed for the simultaneous estimation of Metformin Hydrochloride and Voglibose in tablet dosage form. The stock solutions were prepared in methanol. The λmax for Metformin Hydrochloride and Voglibose were found to be248 nm and 287nm respectively. The Metformin Hydrochloride and Voglibose obeyed Beer’s law in concentration range of 8-16µg/ml and 4-20µg/ml respectively. Results of analysis of absorbance ratio method were analysed and validated for various parameters according to ICH guidelines for accuracy, precision, linearity, robustness, LOD and LOQ. The proposed method is highly sensitive, precise and accurate, therefore can be used for intended purpose.

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DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC Q-ABSORBANCE RATIO METHOD FOR SIMULTANEOUS ESTIMATION OF EPERISONE HYDROCHLORIDE AND ACECLOFENAC IN BULK AND TABLET DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.55.11.11327 ◽

2018 ◽

Vol 55 (11) ◽

pp. 50-56

Author(s):

M. Simoes ◽

◽

L. Almeida

Keyword(s):

Dosage Form ◽

Limit Of Detection ◽

Ratio Method ◽

Simultaneous Estimation ◽

Absorbance Ratio ◽

Ich Guidelines ◽

Relative Standard ◽

Limit Of Quantitation ◽

Development And Validation ◽

Tablet Dosage

A simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method has been developed for the simultaneous estimation of eperisone hydrochloride and aceclofenac in combined dosage form. The solvent used was methanol:water (70:30 v/v). The iso-absorptive point was found to be 269.5 nm. Calibration curves were linear over a concentration range of 6-21 μg/ml for eperisone hydrochloride and 8-28 μg/mL for aceclofenac, respectively. The developed method was validated as per International Conference on Harmonization (ICH) guidelines for various parameters such as linearity, precision, accuracy, limit of detection and limit of quantitation. Accuracy of method was determined through recovery studies which were found to be 99.0% - 100.89 % for eperisone hydrochloride and 98.67% - 100.44 % for aceclofenac. Method was found to be reproducible with relative standard deviation (RSD) for intra-and inter-day precision less than 2% over the concentration range. The proposed method can be used for routine analysis of eperisone hydrochloride and aceclofenac in bulk and tablet dosage form.

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Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form

International Journal of Spectroscopy ◽

10.1155/2014/873819 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Monika L. Jadhav ◽

Manoj V. Girase ◽

Shripad K. Tidme ◽

Manish S. Junagade

Keyword(s):

Dosage Form ◽

Pharmaceutical Formulations ◽

Simultaneous Equation ◽

Ratio Method ◽

Simultaneous Estimation ◽

Spectrophotometric Methods ◽

Absorbance Ratio ◽

Standard Additions ◽

Development And Validation ◽

Tablet Dosage

Two UV-spectrophotometric methods have been developed and validated for simultaneous estimation of valsartan and hydrochlorothiazide in a tablet dosage form. The first method employed solving of simultaneous equations based on the measurement of absorbance at two wavelengths, 249.4 nm and 272.6 nm, λmax for valsartan and hydrochlorothiazide, respectively. The second method was absorbance ratio method, which involves formation of Q-absorbance equation at 258.4 nm (isoabsorptive point) and also at 272.6 nm (λmax of hydrochlorothiazide). The methods were found to be linear between the range of 5–30 µg/mL for valsartan and 4–24 μg/mL for hydrochlorothiazide using 0.1 N NaOH as solvent. The mean percentage recovery was found to be 100.20% and 100.19% for the simultaneous equation method and 98.56% and 97.96% for the absorbance ratio method, for valsartan and hydrochlorothiazide, respectively, at three different levels of standard additions. The precision (intraday, interday) of methods was found within limits (RSD<2%). It could be concluded from the results obtained in the present investigation that the two methods for simultaneous estimation of valsartan and hydrochlorothiazide in tablet dosage form are simple, rapid, accurate, precise and economical and can be used, successfully, in the quality control of pharmaceutical formulations and other routine laboratory analysis.

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ABSORBANCE RATIO METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN HYDROBROMIDE HYDRATE (TENE) AND METFORMIN HYDROCHLORIDE (MET) IN TABLET DOSAGE FORM

International Research Journal of Pharmacy ◽

10.7897/2230-8407.0917 ◽

2018 ◽

Vol 9 (1) ◽

pp. 47-55

Author(s):

Hardi Joshi ◽

Avani Khristi

Keyword(s):

Dosage Form ◽

Method Development ◽

Ratio Method ◽

Metformin Hydrochloride ◽

Simultaneous Estimation ◽

Absorbance Ratio ◽

Method Development And Validation ◽

Development And Validation ◽

Tablet Dosage

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PENGEMBANGAN DAN VALIDASI METODE KROMATOGRAFI CAIR KINERJA TINGGI (KCKT) UNTUK ESTIMASI KADAR SIMULTAN ANTIEMETIK PIRIDOKSIN HIDROKLORIDA DAN PIRATIAZIN TEOKLAT DALAM BENTUK SEDIAAN TABLET

Kartika Jurnal Ilmiah Farmasi ◽

10.26874/kjif.v6i2.187 ◽

2019 ◽

Vol 6 (2) ◽

pp. 95

Author(s):

Fikri Alatas ◽

Hernandi Sujono ◽

Woro Artati Sucipto

Keyword(s):

High Performance Liquid Chromatography ◽

Liquid Chromatography ◽

High Performance ◽

Dosage Form ◽

Ultra Violet ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pyridoxine Hydrochloride ◽

Development And Validation ◽

Tablet Dosage

Abstrak Metode kromatografi cair kinerja tinggi (KCKT) dengan detektor ultra lembayung telah dikembangkan dan divalidasi untuk estimasi kadar secara simultan campuran piridoksin hidroklorida (PH) dan piratiazin teoklat (PT)dalam sediaan tablet antiemetik. Proses pemisahan terjadi dalam kolom Inertsil® ODS-3 pada panjang gelombang 280 nm dengan laju alir 1,0 mL/menit. Fase gerak yang optimal untuk pemisahan adalah campuran methanol-asam asetat 1% (20:80) dengan waktu retensi PH dan PT berturut-turut adalah 1,2 dan 9,8 menit. Perolehan kembali PH dan PT berturut-turut adalah 100,13 dan 99,78 %. Batas deteksi untuk PH dan PT berturut-turut adalah 0,21 dan 0,22 µg/mL, sedangkan batas kuantisasinya berturut-turut adalah 0,70 dan 0,72 µg/mL. Metode ini dapat diterapkan sebagai metode untuk estimasi kadar campuran piridoksin hidroklorida dan piratiazin teoklat dalam bentuk sediaan tablet secara simultan. Kata kunci: Piridoksin hidroklorida, piratiazin teoklat, KCKT, tablet Development and validation of high performance liquid chromatography (HPLC) method for simultaneous estimation of antiemetic pyridoxyne hydrochloride and pyrathiazine theoclate in tablet dosage form Abstract The high performance liquid chromatography (HPLC) method with an ultra violet detector has been developed and validated for simultaneous estimation of pyridoxine hydrochloride (PH) and pyrathiazine theoclate (PT) in antiemetic tablet preparations. The separation process occurs in the Inertsil® ODS-3 column at a wavelength of 280 nm with a flow rate of 1.0 mL /min. The optimal mobile phase for separation is a mixture of methanol-acetic acid 1% (20:80) with the retention times of PH and PT 1.2 and 9.8 minutes respectively. The recoveries of PH and PT were 100.13 and 99.78%, respectively. The detection limits for PH and PT were 0.21 and 0.22 µg / mL respectively, while the quantisation limits were 0.70 and 0.72 µg / mL, respectively. This method can be applied as a method for simultaneous estimating the levels of pyridoxine hydrochloride and pyrathiazine theoclate in tablet dosage form. Keywords: Pyridoxine hydrochloride, pyrathiazine theoclate, HPLC, tablet

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SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND INDAPAMIDE BY DUAL WAVELENGTH SPECTROPHOTOMETRIC METHOD FOR COMBINED PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.51.04.p0050 ◽

2014 ◽

Vol 51 (04) ◽

pp. 50-54

Author(s):

M. P Patel ◽

◽

M. R Patel ◽

R Hasumati ◽

M. N Noolvi ◽

...

Keyword(s):

Spectrophotometric Method ◽

Dosage Form ◽

Dual Wavelength ◽

Simultaneous Estimation ◽

Uv Spectrophotometry ◽

Amlodipine Besylate ◽

Pharmaceutical Dosage Form ◽

First Order ◽

Absorbance Difference ◽

Tablet Dosage

A simple, accurate, precise, rapid, economical UV spectrophotometry method, dual wavelength spectrophotometry, has been developed and validated for estimation of Indapamide (IND) and Amlodipine besylate (AML) in combined tablet dosage form and can be used in routine analysis. In this method, the absorbance at 360 nm and 256 nm of AML were same and no interference of IND at 360 nm. was observed. So, absorbance difference at 256-360 is used for estimation of IND and absorbance at 360 nm used for AML. The method was found to be linear in the concentration range of 3-18 μg/mL for IND (r2>0.99962) and 10-60 μg/mL for AML (r2>0.99969). Mean assay was found to be 99.32% and 101.34% for IND and AML respectively. In first order derivative spectrophotometry, the absorbance at 237.4 nm (ZCP of AML) and 241 nm (ZCP of IND) were used for estimation of IND and AML respectively. The method was found to be linear in the concentration range of 1.5-9 μg/mL for IND(r2=0.99983) and 5-30 μg/mL for AML(r2=0.99966). Mean assay was found to be 99.72% and 100.28% for IND and AML respectively.

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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NEW STABILITY-INDICATING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN TABLET DOSAGE FORM

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2019.v12i1.26537 ◽

2019 ◽

Vol 12 (1) ◽

pp. 241 ◽

Cited By ~ 1

Author(s):

Geetha Susmita A ◽

Rajitha G ◽

Ramya Yadav Y ◽

Uma P

Keyword(s):

High Performance Liquid Chromatography ◽

Liquid Chromatography ◽

High Performance ◽

Dosage Form ◽

Simultaneous Estimation ◽

Reverse Phase ◽

Stability Indicating ◽

Rp Hplc ◽

Relative Standard ◽

Tablet Dosage

Objective: The objective of this study was to develop and validate a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of the metformin and empagliflozin in tablet dosage forms.Methods: The chromatographic conditions were optimized and it was run through Std. BDS (250 mm × 4.6 mm, 5 m) column with mobile phase consisting of 0.1% orthophosphoric acid buffer: acetonitrile in the ratio of 50:50. The flow rate was 1 ml/min and optimized wavelength was 210 nm. Temperature was maintained at 30°C.Results: The retention times of metformin and empagliflozin were found to be 2.588 min and 3.679 min and percentage relative standard deviation (RSD) of the metformin and empagliflozin was found to be 0.59 and 1.2, respectively. Percentage recovery was in the range of 100.01–100.65% for metformin and empagliflozin, respectively.Conclusion: A sensitive, rapid, and specific method has been developed for the simultaneous estimation of metformin and empagliflozin using RP-HPLC in tablet dosage form.

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