SIMULTANEOUS ESTIMATION OF EMITRICITABINE, EFAVIRENZ, TENOFOVIR DISPROXIL FUMARATE BY CHEMOMETRY AND REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (06) ◽  
pp. 62-69
Author(s):  
G. Ramya Kumari ◽  
◽  
N. C Deepika ◽  
Krishnamurthy Bhat
Keyword(s):  
High Performance ◽  
Ultra Violet ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Partial Least Square ◽  
Least Square ◽  
Ternary Mixtures ◽  
Data Matrix ◽  
Simultaneous Estimation ◽  
Tenofovir Df

A chemometric ultra-violet spectrophotometric method of analysis, Partial Least Square (PLS) method was applied to simultaneous assay of emitricitrabine, efavirenz and tenofovir disoproxil fumarate (DF) in their combined dosage tablet formulation. For comparison of this chemometric method a HPLC method for simultaneous determination of emitricitabine, efavirenz and tenofovir DF in combination was developed. Twenty one mixed solutions were prepared for chemometric calibration set and twenty one ternary mixtures were prepared as validation sets. The absorbance data matrix for training set was obtained by recording absorbance within wavelength range 230-290 nm at 2nm intervals. The developed multivariate and HPLC methods were successfully tested for laboratory mixtures as well as commercial tablet formulation of emitricitrabine, efavirenz, tenofovir DF.

DEVELOPMENT AND VALIDATION OF CHEMOMETRIC-ASSISTED UV-SPECTROPHOTOMETRIC METHOD FOR EPIGALLOCATECHIN GALLATE AND CURCUMIN IN TABLET FORMULATION

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (04) ◽  
pp. 45-51
Author(s):  
N. C. Patel ◽  
A. P. Patel ◽  
J. K. Patel
Keyword(s):  
Epigallocatechin Gallate ◽  
Tablet Formulation ◽  
Partial Least Square ◽  
Least Square ◽  
Data Matrix ◽  
Simultaneous Estimation ◽  
Calibration Data ◽  
Mixed Solution ◽  
Validation Set ◽  
Development And Validation

A chemometric method, Partial Least Square, was applied for the simultaneous estimation of epigallocatechin gallate and curcumin in tablet formulation. Twenty five mixed sample solutions were prepared for chemometric calibration as training set and sixteen mixed solution for validation set using Full Factorial Design. The absorbance data matrix was obtained by measuring absorbance at 20 different wavelengths in the range of 220 to 410 nm (Δλ = 10 nm). The developed calibration data was used to test tablet formulation containing epigallocatechin gallate and curcumin. The developed methods were validated using RMSECV and RMSEP. The chemometric calculations were performed using Minitab 16.1.1 and Microsoft Excel 2010. The method is also more accurate and precise than conventional UV methods.

scholarly journals Development and validation of chemometric assisted analytical methods for simultaneous estimation of Atorvastatin calcium and Aspirin in capsule dosage form

2019 ◽  
Vol 10 (3) ◽  
pp. 1692-1697
Author(s):  
Keerthisikha Palur ◽  
BharathiKoganti ◽  
Sreenivasa Charan Archakam
Keyword(s):  
Analytical Methods ◽  
Dosage Form ◽  
Hplc Method ◽  
Partial Least Square ◽  
Least Square ◽  
Partial Least Square Regression ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Atorvastatin Calcium ◽  
Rp Hplc

To develop two Chemometric-assisted analytical methods like UV spectrophotometry and RP-HPLC methods for the quantification of Atorvastatin calcium (ASC) and Aspirin (APN) in the capsule dosage form. Chemometric models used in UV spectrophotometry were Principal component regression model (PCRM) and Partial least-square regression (PLSR). Both the models were applied for the drugs in the calibration ranges of 4-20 and 30-150 μg/mL for ASC and APN respectively. Total of nineteen laboratory prepared mixtures were used for calibration and prediction set of the models. In addition, RP-HPLC method by using chemometric approach for was developed using C18 column at room temperature with a mobile phase of acetonitrile: methanol: triethylamine (53.1:11.9:35 v/v/v), pH- 3.0, with detection at 275 nm. PCRM and PLSR models were evaluated by statistical parameters and RP-HPLC method was optimized by using Response surface methodology. The developed methods like UV and RP-HPLC by using chemometrics showed almost similar results and both the methods can be used for their analysis.

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

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

<p align="center"><strong>Abstrak</strong><strong></strong></p><p align="center"><strong> </strong></p><p>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.</p><p> </p><p><strong>Kata kunci:</strong> Piridoksin hidroklorida, piratiazin teoklat, KCKT, tablet</p><p> </p><p align="center"><strong><em>Development and validation of high performance liquid chromatography (HPLC) method for simultaneous estimation of antiemetic pyridoxyne hydrochloride and pyrathiazine theoclate in tablet dosage form</em></strong></p><p> </p><p align="center"><strong><em>Abstract</em></strong><strong><em></em></strong></p><p><em> </em></p><p><em>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.</em><em></em></p><p><em> </em></p><p><strong><em>Keywords:</em></strong><em> Pyridoxine hydrochloride, pyrathiazine theoclate, HPLC, tablet</em></p>

CHEMOMETRICS ASSISTED SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF SOFOSBUVIR AND DACLATASVIR DIHYDROCHLORIDE IN TABLET FORMULATION

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (03) ◽  
pp. 37-46
Author(s):  
Sapna M Rathod ◽  
Paresh U Patel
Keyword(s):  
Method Development ◽  
Spectroscopic Method ◽  
Principal Component ◽  
Tablet Formulation ◽  
Partial Least Square ◽  
Least Square ◽  
Simultaneous Estimation ◽  
Mixed Solution ◽  
Chemometric Methods ◽  
Validation Set

Four chemometric methods, namely Classical Least Square (CLS), Inverse Least Square (ILS), Partial Least Square (PLS) and Principal Component Regression (PCR), were developed for the simultaneous estimation of sofosbuvir and daclatasvir dihydrochloride in tablet formulation. Full factorial design was used to construct calibration set as well as validation set. Twenty five mixed solutions were prepared for calibration set and sixteen mixed solution of drugs were prepared for validation set. The absorbance of all prepared solutions was measured in the range of 230 nm to 335 nm at 16 wavelength points at an interval of 7 nm. Linearity was observed in the range of 10 – 90 µg/mL for sofosbuvir and 4 - 20 µg/mL for daclatasvir dihydrochloride. The developed chemometric methods were validated in terms of precision and accuracy as per ICH guidelines. The developed methods can be applied for the routine quantitative analysis of formulation.

scholarly journals STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND CLOPIDOGREL BISULFATE IN PHARMACEUTICAL DOSAGE FORM BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2020 ◽  
pp. 84-90
Author(s):  
AWDHUT PIMPALE ◽  
RAJENDRA KAKDE
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Tablet Formulation ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Clopidogrel Bisulfate ◽  
Rp Hplc ◽  
Development And Validation

Objective: The present work was focused on the development and validation of reversed-phase high-performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of rosuvastatin (RSV) calcium and clopidogrel bisulfate (CLO) in bulk and tablet formulation. Methods: The separation was attained on RP Princeton (C18) column with dimensions (250 mm × 4.6 mm, 5 μ) employing buffer which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid), and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min and detection was carried out at wavelength 240 nm. The retention time under the optimized condition of RSV calcium and CLO was found to be 2.844 min and 4.388 min, respectively. Results: The linearity of the method was demonstrated in the concentration range of 6–16 µg/ml and 45–120 µg/ml for RSV calcium and CLO with a correlation coefficient (r2) of 0.9999 and 0.9996, respectively. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12–101.37% and 99.72–101.09% for RSV calcium and CLO, respectively. Assay of marketed tablet formulation was found to be 98.99% and 99.92%, respectively. Conclusion: The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical and could be used for regular quality control of RSV calcium and CLO in bulk and tablet formulations.

SIMULTANEOUS ESTIMATION OF TELMISARTAN, HYDROCHLOROTHIAZIDE AND AMLODIPINE BESYLATE IN TABLET PREPARATION BY CHEMOMETRIC ASSISTED SPECTROPHOTOMETRIC ANALYSIS

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (07) ◽  
pp. 59-66
Author(s):  
A. S Ghule ◽  
T. Thomas ◽  
M. Joseph ◽  
K. S. Navya Sree ◽  
K. Bhat
Keyword(s):  
Spectrophotometric Analysis ◽  
Partial Least Square ◽  
Least Square ◽  
Partial Least Square Regression ◽  
Data Matrix ◽  
Simultaneous Estimation ◽  
Amlodipine Besylate ◽  
Mixed Solutions ◽  
Validation Set ◽  
Tablet Preparation

A chemometric method was developed by application of Partial Least Square regression to for the simultaneous estimation of telmisartan, hydrochlorothiazide and amlodipine besylate in tablet preparations. Calibration set was prepared considering seven sets; each set with twenty-four mixed solutions and twenty-one ternary mixed solutions, were prepared as a validation set. The absorbance data matrix for training set was obtained by recording absorbance within wavelength range 220-320 nm at 2nm intervals. The developed method was validated according to ICH Q2 (R1) guidelines and results were reported. The developed and validated multivariate method was successfully tested for laboratory mixtures as well as commercial tablet formulation of telmisartan, hydrochlorothiazide and amlodipine besylate.

Comparison of Chemometric assisted UV Spectrophotometric and RP-HPLC Method for the simultaneous determination of Ofloxacin and Tinidazole in their Combined dosage form

2021 ◽  
pp. 5713-5718
Author(s):  
Santosh V. Gandhi ◽  
Deepak Patil ◽  
Atul A. Baravkar
Keyword(s):  
Simultaneous Determination ◽  
Dosage Form ◽  
Hplc Method ◽  
Partial Least Square ◽  
Least Square ◽  
Partial Least Square Regression ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

In present work, chemometric-assisted UV spectrophotometric methods as well as RP-HPLC method were developed for the simultaneous estimation of Ofloxacin and Tinidazole in their combined pharmaceutical dosage form. The two chemometric methods i.e. principle component regression (PCR) and partial least square regression (PLS) were successfully applied to quantify each drug in mixture using UV absorption spectra in range of 280 to 320nm at ∆λ of 0.5nm. Chemometric model development was done using 24 binary mixture solutions and 12 solutions were used for validation of model. The chemometric-assisted analysis does not require any prior separation step. In addition, RP-HPLC method was also developed using THERMOSIL C18 column with a mobile phase consisting ofAcetonitrile: Phosphate Buffer (85:15% v/v), flow rate of 1 ml/min and quantification was achieved using UV detector at 300 nm. The methods were successfully applied for the simultaneous determination of these drugs in synthetic mixture. The results obtained for analysis by PCR and PLS methods were compared with RP-HPLC method and a good agreement was found.

scholarly journals A Novel Validated Injectable Colistimethate Sodium Analysis Combining Advanced Chemometrics and Design of Experiments

Molecules ◽  
2021 ◽  
Vol 26 (6) ◽  
pp. 1546
Author(s):  
Ioanna Dagla ◽  
Anthony Tsarbopoulos ◽  
Evagelos Gikas
Keyword(s):  
Design Of Experiments ◽  
High Performance ◽  
Similarity Index ◽  
Principal Component ◽  
Partial Least Square ◽  
Least Square ◽  
Partial Least Square Regression ◽  
Distance Measures ◽  
Linear Regression Models ◽  
Colistimethate Sodium

Colistimethate sodium (CMS) is widely administrated for the treatment of life-threatening infections caused by multidrug-resistant Gram-negative bacteria. Until now, the quality control of CMS formulations has been based on microbiological assays. Herein, an ultra-high-performance liquid chromatography coupled to ultraviolet detector methodology was developed for the quantitation of CMS in injectable formulations. The design of experiments was performed for the optimization of the chromatographic parameters. The chromatographic separation was achieved using a Waters Acquity BEH C8 column employing gradient elution with a mobile phase consisting of (A) 0.001 M aq. ammonium formate and (B) methanol/acetonitrile 79/21 (v/v). CMS compounds were detected at 214 nm. In all, 23 univariate linear-regression models were constructed to measure CMS compounds separately, and one partial least-square regression (PLSr) model constructed to assess the total CMS amount in formulations. The method was validated over the range 100–220 μg mL−1. The developed methodology was employed to analyze several batches of CMS injectable formulations that were also compared against a reference batch employing a Principal Component Analysis, similarity and distance measures, heatmaps and the structural similarity index. The methodology was based on freely available software in order to be readily available for the pharmaceutical industry.

scholarly journals A Simple and Sensitive HPLC Method for Simultaneous Analysis of Nabumetone and Paracetamol in Pharmaceutical Formulations

2011 ◽  
Vol 8 (s1) ◽  
pp. S41-S46
Author(s):  
Prafulla Kumar Sahu ◽  
M. Mathrusri Annapurna ◽  
Dillipkumar Sahoo
Keyword(s):  
High Performance ◽  
Internal Standard ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Aqueous Acetic Acid ◽  
Linear Calibration ◽  
Acceptance Range ◽  
Liquid Chromatographic

This paper describes a high-performance liquid chromatographic method for simultaneous estimation of nabumetone and paracetamol in binary mixture. The method was based on RP-HPLC separation and quantitation of the two drugs on hypersil C-18 column (250 mm × 4.6 mm) using a mobile phase consisting of acetonitrile and 0.05% aqueous acetic acid (70:30v/v) at flow rate of 1 mL min-1. Quantitation was achieved with PDA detector at 238 nm based on peak area with linear calibration curves at concentration ranges 5-25 µg mL-1for both the drugs. Naproxen sodium was used as internal standard. The method has been successively applied to pharmaceutical formulation. No chromatographic interference from the tablet excipients was found. The method was validated in terms of precision, robustness, recovery and limits of detection and quantitation. The intra and inter-day precision and accuracy values were in the acceptance range as per ICH guidelines.

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE IN PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 35-40
Author(s):  
A. S. Bagde ◽  
V. V. Khanvilkar ◽  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Dextromethorphan Hydrobromide

The present work describes a validated reverse phase high performance liquid chromatography (RPHPLC) method for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate in pharmaceutical dosage from. The drugs were resolved using Hemochrom Intsil C18-5U column (250×4.6) mm in isocratic mode with mobile phase methanol: water (0.08% diethylamine, 0.02% of glacial acetic acid and pH 4.4 adjusted with orthophosphoric acid) in the ratio of 70:30 V/V at a flow rate of 1.0 mL/min. Retention time of dextromethorphan hydrobromide and quinidine sulphate were 4.9±0.2 and 3.6±0.2, respectively, at 292nm. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines. Linear responses were obtained in concentration ranges of 5-35 μg/mL for dextromethorphan hydrobromide and 4-16 μg/mL for quinidine sulphate, with correlation coefficient (r2) of 0.999 for both the drugs. A simple, selective, accurate, precise, robust and reliable RP-HPLC method thus developed and validated for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate.

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