Method For Simultaneous Estimation Research Articles

Development and validation of a UV spectrophotometric method for simultaneous estimation of teneligliptin hydrobromide hydrate and pioglitazone hydrochloride in pharmaceutical dosage form

BackgroundThis study presents the development and validation of a UV spectrophotometric method for the simultaneous estimation of teneligliptin hydrobromide hydrate (TEN) and pioglitazone hydrochloride (PIO) in pharmaceutical dosage forms. The method measures absorbance at 243 nm for TEN and 265 nm for PIO. Validation was conducted according to ICH guidelines, covering specificity, linearity, range, precision, accuracy, limit of detection, limit of quantification, and robustness.ResultsThe method exhibited linearity in the 2–25 µg/ml concentration range for both TEN and PIO, with correlation coefficients close to 1. Precision studies showed low % RSD values, indicating excellent repeatability and minimal intra- and inter-day variability. Accuracy was confirmed through recovery studies, with results within the 98–102% range. The method demonstrated sensitivity with low LOD and LOQ values. Robustness testing showed stability and consistency under varying conditions. Analysis of tablet formulations confirmed the accurate quantification of both drugs.ConclusionThe developed UV spectrophotometric method offers a simple, sensitive, and cost-effective solution for the simultaneous estimation of TEN and PIO in pharmaceutical formulations. It is suitable for routine analysis and quality assessment of tablet dosage forms.

Eco-friendly HPTLC method for simultaneous estimation of gallic acid, ellagic acid, and curcumin biomarker in herbal formulation

Eco-friendly HPTLC method for simultaneous estimation of gallic acid, ellagic acid, and curcumin biomarker in herbal formulation

A new method development and validation for simultaneous estimation of ramipril and telmisartan by RP-HPLC method in combined dosage form

The present research work was development and validation of new RP-HPLC method for simultaneous estimation of Ramipril and Telmisartan in combined dosage form. In simultaneous RP-HPLC method development, Waters 2695 Separations Module with PDA Detector and column used is C8 SB ZORBAX (150 X 4.6mm) column with 3.5-micron particle size. Injection volume of 10 µL is injected and eluted with the mobile phase selected after optimization was Phosphate buffer and Acetonitrile in the ratio of 70:30 was found to be ideal. The optimized flow rate was at 1.0 mL/min. Detection was carried out at 230 nm. This system produced symmetric peak shape, good resolution and reasonable retention times of Ramipril and Telmisartan were found to be 2.275 and 4.261 minutes respectively. The Ramipril and Telmisartan showed linearity in the range of 20-60 µg/mL and 160-480 µg/mL respectively. The %RSD values for precision was found to be within the acceptable limit, which revealed that the developed method was precise. The developed method was found to be robust and the %RSD value for percentage recovery of Ramipril and Telmisartan was found to be within the acceptance criteria. The results indicate satisfactory accuracy of method for simultaneous estimation of the Ramipril and Telmisartan.

Spectrometric method for simultaneous quantification of nadifloxacin and salicylic acid in a novel topical dosage form

Acne vulgaris is a prevalent skin disorder that affects many individuals. In the search for effective acne therapy, researchers have found that a combination of Nadifloxacin and Salicylic Acid may produce a synergistic effect. To further investigate this, a study was conducted to devise a spectrophotometric method for simultaneously measuring the concentrations of Nadifloxacin and Salicylic Acid in a novel topical formulation. Simultaneous Estimation Method was employed using methanol as the solvent. Nadifloxacin exhibited an absorbance maximum of 291 nm, while Salicylic Acid showed an absorbance maximum of 297 nm in methanol. Linearity experiments were conducted to determine the concentration ranges for both drugs, which were found to be 2–12 ppm for Nadifloxacin and 5–30 ppm for Salicylic Acid. The recovery results of Nadifloxacin ranged from 82 % to 95 %, while those of Salicylic Acid ranged from 97 % to 110 %. These results indicate the accuracy and reliability of the method. This method was further validated in accordance with the guidelines provided by the International Council for Harmonization (ICH) of Technical Requirements for Human Use. The proposed method has demonstrated its applicability for the simultaneous and quantitative assessment of Nadifloxacin and Salicylic Acid in various dosage forms. This development is significant as it provides a reliable and efficient means of measuring the concentrations of these two drugs in acne therapy formulations.

High Performance Thin Layer Chromatographic Method for Simultaneous Estimation of Vitamin C, Thymoquinone and Thymol in Plant Extracts

Background: Lack of an effective HPTLC simultaneous estimation method for vitamin C, thymoquinone and thymol in plant extracts. Aim: The present study involves the development of an accurate, precise, specific, and specific HPTLC method for the identification and quantification of three phytomarkers thymol and thymoquinone in Nigella sativa (kali jiri) seed extract and vitamin C in Hylocereus polyrhizus (dragon fruit) extract. Methods: Using an aluminum plate pre-coated with silica gel 60 F254 and methanol-n hexane-ammonia (15%) (8.5:1.5:0.2 v/v/v) as the mobile phase, thin layer chromatographic development was performed. Results: For each of the three markers, densitometric quantification was carried out at the isobestic point of 271 nm. Vitamin C, thymol, and thymoquinone bands were separated chromatographically at Rf values of 0.66, 0.35, and 0.19, respectively, by using developed mobile phase. For thymol, thymoquinone, and vitamin C, linearity range was 2000-8000 ng/band. The three markers showed 99.39%–99.91% recovery for thymol, 99.22%–99.89% recovery for thymoquinone, and 99.19%–99.69% recovery for vitamin C. Conclusion: The optimized method was used to quantify three thymol and thymoquinone in N. sativa (kali jiri) seed extract and vitamin C in H. polyrhizus (dragon fruit) extract.

Simultaneous Estimation of Atazanavir & Ritonavir in API & Marketed Formulations by Using RP-HPLC

Development and validation of RP-HPLC method for simultaneous estimation of Atazanavir and Ritonavir in their combined tablet dosage form. Atazanavir and Ritonavir are antiviral agents used in treatment of HIV. A simple, precise, rapid, accurate and cost-effective high- performance liquid chromatography (HPLC) method was successfully developed and validated for simultaneous estimation of Atazanavir and Ritonavir in their combined tablet dosage form. The selected mobile phase was Methanol: Phosphate Buffer in proportion 65:35 v/v respectively. The optimized columns used are C18 column, Symmetry and Zodiac column. X bridge C18 (4.6×150 mm, 5 µm) particle size was found to be ideal as it gave good peak shape and resolution at 1ml/min flow for Atazanavir and Ritonavir. In this study, the validation of Atazanavir and Ritonavir in API and marketed formulations were performed keeping in accordance with the parameters like system suitability, specificity, linearity, accuracy, precision (reproducibility & repeatability), robustness. The developed stability indicating method is capable for determination of impurities of Atazanavir and Ritonavir in combined tablet dosage form as well as individual dosage forms also. The method has been successfully validated according to ICH guidelines and the results obtained by using RP – HPLC are rapid, accurate and precise. The proposed methods were successfully applied for the analysis of synthetic mixtures and pharmaceutical formulations of Atazanavir and Ritonavir.

Analytical Quality by Design (AQbD) Principles in Development and Validation of Stability‐Indicating RP‐HPLC Method for Simultaneous Estimation of Diltiazem HCl and Eugenol in Nanoethosomes

ABSTRACTThe study developed and validated a robust reverse‐phase high‐performance liquid chromatography (RP‐HPLC) method for a simultaneous estimation of Diltiazem HCl and Eugenol in nanoethosomes using analytical quality by design (AQbD) principles. The optimized method utilized a mobile phase of methanol and 0.1% Orthophosphoric acid (OPA) in a 50:50 % v/v ratio, with a flow rate of 1.0 mL/min and isocratic elution on a Phenomenex Luna C‐18 column (5 µm, 150 mm × 4.6 mm) at 30°C. This setup resulted in retention times of 6.838 min for Diltiazem HCl and 23.135 min for Eugenol. Validation followed International Council for Harmonization (ICH) Q2 (R1) guidelines, demonstrating excellent linearity with correlation coefficients of 0.9982 for Diltiazem HCl and 0.9991 for Eugenol across the 5–25 µg/mL range. The limits of detection (LOD) were 1.341 µg/mL for Diltiazem HCl and 0.960 µg/mL for Eugenol, with limits of quantification (LOQ) at 4.065 and 2.912 µg/mL, respectively. Stability testing under acidic, alkaline, oxidative, thermal, and photolytic conditions adhered to ICH Q1A (R2) and Q1B guidelines. This AQbD‐based method is effective for routine analysis of Diltiazem HCl and Eugenol in bulk and pharmaceutical dosage forms, fully complying with ICH standards.

A Liquid Chromatography Coupled to Tandem Mass Spectrometry Method for Simultaneous Estimation of Saxagliptin and Avanafil: Application to Pharmacokinetic Drug‐Drug Interaction in Type 2 Diabetic Rat Model

ABSTRACTErectile dysfunction is a common complication of type 2 diabetes. The combination of saxagliptin and avanafil can effectively manage both conditions in individuals with type 2 diabetes. However, evaluating the potential pharmacokinetic interactions for co‐administration of saxagliptin and avanafil is crucial. Here, we developed a sensitive bioanalytical method for simultaneously quantifying saxagliptin and avanafil in rat plasma using liquid chromatography hyphenated to triple quadrupole mass spectrometry. The chromatographic separation of saxagliptin, avanafil, and irbesartan (internal standard) was achieved on an Aquity BEH C18 column (100 × 2.1 mm, 1.7 µm), using 0.1% formic acid in water and acetonitrile as mobile phase with the gradient elution at a flow rate of 0.2 mL/min. Mass detection was carried out using selective reaction monitoring mode, with the product ions for saxagliptin, avanafil, and irbesartan being 180.2, 375.1, and 207.1 m/z, respectively. The developed liquid chromatography coupled to tandem mass spectrometry method was validated as per the US Food and Drug Administration guidelines in rat plasma. The validation findings confirmed the method's robustness and suitability for accurate quantification of saxagliptin and avanafil in rat plasma with the limit of quantification of 1 ng/mL for both the drugs and were linear in the range of 1–2000 ng/mL. The study found no significant pharmacokinetic interaction between saxagliptin and avanafil, suggesting they can be safely co‐administered to patients with type 2 diabetes.

Development and Validation of New Stability Indicating Analytical RPHPLC Method for Simultaneous Estimation of Metformin and Alogliptin.

The current study focuses on developing and validating a reverse phase-high performance liquid chromatography (RP-HPLC) method for quantifying metformin HCL (MET) and alogliptin (ALO) in both dosage and bulk drug forms. ALO and MET in tablet form were determined simultaneously using an RP-HPLC technique. The Reverse Phase (Waters) C18 (4.6 mm x 150 mm; 5 µ) column, a 20-injection loop are the components of the gradient system for the RP manufactured by Agilent Technologies. In the procedure, a 50:50 volumetric combination of methanol and water (0.1% acetic acid) was used as the mobile phase at pH 4.5. The developed approach yielded retention times of 3.856 minutes for MET and 6.302 minutes for ALO. The reliability of the established technique was demonstrated in compliance with the International Council of Harmonization (ICH) standards. In general, all of the metrics including linearity, accuracy, range, and robustness, were found to be within the acceptable ranges. Consequently, the methodology was assessed to be simple, precise, cost-effective, and replicable. Hence, the analysis of MET and ALO in both bulk medication and formulated states can be regularly conducted utilising the procedures specified for the purpose of quality control.

Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Metformin, Tenegliptin, and Pioglitazone in bulk and its Pharmaceutical Dosage Form .

A straightforward, reliable, and thorough approach was created for contemporaneously estimating Teneligliptin, Metformin, and Pioglitazone in solid dosage form. It was conducted by means of Agilent C18 150x4.6mm, 5µ. The mobile phase comprising buffer, acetonitrile, and Methanol (55:35:10 v/v) passed across the column at a pace of 0.9ml/min. The procedure relied on a 0.01N K2HPO4 buffer having a pH of 3.5, which was achieved by diluting an orthophosphoric acid solution. The temperature was kept constant at 30°C—optimized wavelength for Teneligliptin. Metformin and Pioglitazone were 220.0 nm. Retention times of Teneligliptin, Metformin, and Pioglitazone were 2.970 min, 2.395 min, and 3.642 min. %RSD of a system for Teneligliptin, Metformin, and Pioglitazone were 1.3, 0.6, and 1.0, respectively. %RSD of a method for Teneligliptin, Metformin, and Pioglitazone was 0.6 for each drug. The % recovery was 100.43, 100.45, and 100.22% for Teneligliptin, Metformin, and Pioglitazone, accordingly. The regression equations are used to generate the LoD and LoQ values of Teneligliptin, Metformin, and Pioglitazone, and LoD values were 0.016 ppm, 0.26 ppm, 0.42ppm, while LOQ values of Teneligliptin, Metformin and Pioglitazone were 0.048 ppm, 0.78 ppm,1.28 ppm respectively. The regression equation of Teneligliptin was y = 56655x + 920.87. Metformin was y = 14194x + 3082.1 and of Pioglitazone was y = = 41330x + 792.61.Reduced retention durations make the new approach easy and cost-effective for use in routine industrial quality control testing.

RP-HPLC method for simultaneous estimation of trifluridine and tipiracil in pure and tablet dosage form

RP-HPLC method for simultaneous estimation of trifluridine and tipiracil in pure and tablet dosage form

A comprehensive reverse phase-HPTLC method for simultaneous estimation of azilsartan medoxomil and chlorthalidone in bulk and tablet dosage form

A comprehensive reverse phase-HPTLC method for simultaneous estimation of azilsartan medoxomil and chlorthalidone in bulk and tablet dosage form

A Brief Review on Dual Wavelength Spectrophotometry: The Simultaneous Estimation Method and its Application

The dual wavelength spectrophotometry is developed and validated for simultaneous estimation of various combinations of two drugs. Dual wavelength method is used to eliminate interference due to absorbance of other drug at sampling wavelengths for one drug. Two wavelengths are selected for each drug in such a way that the difference in absorbance is zero for the second drug. The principle for dual wavelength method is the absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest and independent of interfering component. The Following review article contains a brief regarding dual wavelength spectrophotometry introduction, principle, examples and application of different pharmaceutical, organic and inorganic compounds.

The First Validation HPTLC Method for Simultaneous Estimation of Beclomethasone Dipropionate and Fusidic Acid in Pure and Pharmaceutical Dosage Form

The First Validation HPTLC Method for Simultaneous Estimation of Beclomethasone Dipropionate and Fusidic Acid in Pure and Pharmaceutical Dosage Form

Development and Validation of Reversed-phase High-performance Liquid Chromatography Method for Simultaneous Estimation of Desonide and Curcumin in Topical Dosage Form

Development and Validation of Reversed-phase High-performance Liquid Chromatography Method for Simultaneous Estimation of Desonide and Curcumin in Topical Dosage Form

Development and validation of a method for the simultaneous estimation of terpinene-4-ol and 1,8-cineole in Melaleuca alternifolia (Maiden & Betche) Cheel and Rosmarinus officinalis L. oil using HPTLC coupled with a QbD approach

This paper comprehends a Quality by design (QbD) approach for development of a simple and precise HPTLC (High performance thin layer chromatography) method for simultaneous estimation of the phytoconstituents terpinen-4-ol and 1,8-cineole found in Melaleuca alternifolia (tea tree oil) and Rosmarinus officinalis (rosemary oil) respectively. The method was optimized by Design expert software using response surface methodology. The chromatographic condition optimized by using software was, mobile phase as hexane: ethyl acetate: glacial acetic acid in the ratio of 8.5:1.5:0.47 % v/v, stationary phase as TLC plates precoated with silica gel 60 F254 at ambient temperature conditions and saturation time 20 min at 366 nm. Optimized conditions were verified and validated as per ICH Q2 (R1) (International council for harmonization of technical requirements of pharmaceuticals for human use) guidelines. The method developed was validated for the parameters such as specificity, linearity, DL, QL, accuracy and precision. This method was then applied for simultaneous estimation of terpinen-4-ol and 1,8-cineole in Melaleuca alternifolia (tea Tree oil) and Rosmarinus officinalis (rosemary oil) respectively.

Stability Indicating Method Development and Validation for the Simultaneous Estimation of N-Acetylcysteine and Acebrophylline in Tablet Dosage form by RP-HPLC

A quick, accurate, precise Stability indicating method for Simultaneous estimation of N-Acetylcysteine and Acebrophylline in Tablet dosage form was developed and validated. Chromatogram was run on Waters C18 (150 x 4.6 mm, 2 μm) Column. Mobile phase containing OPA Buffer and Methanol taken in a ratio of 10:90 % v/v was pumped at a flow rate of 1.5 mL/min through column. Cushion utilized in this strategy was OPA. Column temperature was kept at 35°C. Injection volume was 5 μL and Run time was 5 minutes. Sample was scanned at 285 nm. RT’s of N-Acetylcysteine and Acebrophylline were found to be 2.646 min and 2.117 min respectively. The developed method was validated and was found to be Accurate, Precise and Linear over the Concentration Range of 25 % to 175 % of Test concentration. Retention time and Runtime are less and the method was properly validated so this method can be utilized for routine analysis and stability studies of Assay of N-Acetylcysteine and Acebrophylline in Tablet dosage form in industries.

Simultaneous determination of Rosuvastatin calcium and Bempedoic acid in fixed-dose combination pharmaceutical dosage forms using RP-HPLC method

A precise, simple, and, accurate method for simultaneous estimation of Rosuvastatin calcium and Bempedoic acid was developed by Reversed phase High-Performance Liquid Chromatographic (RP-HPLC). The validation of the developed method is done as per ICH guidelines. The method was developed on Waters HPLC using a Kromasil 100-5-C18 (4.6 × 250 mm) column with a detection wavelength of 220 nm. The mobile phase consists of 0.1 % OPA in water: Acetonitrile (50:50 v/v). The retention time for Rosuvastatin calcium and Bempedoic acid was found as 5.4 and 10.7 min respectively. The linearity range was established between 10.0–100.0 µg/ml for Rosuvastatin calcium and 45.0–450.0 µg/ml for Bempedoic acid. The correlation coefficients (r2 values) for Rosuvastatin calcium and Bempedoic Acid were 0.9985 and 0.9988 respectively, indicating a strong concentration–response relationship. The method was found to be specific as there was no interference with the peak of Rosuvastatin calcium and Bempedoic acid in presence of excipients. The % Recovery of the method was found to be 98.64 %, 99.35 %, and 98.27 % for Rosuvastatin calcium and 99.11 %, 99.16 %, and 99.46 % for Bempedoic Acid. Therefore, the method has good trueness. Repeatability analysis of 6 samples revealed %RSD values of 0.92 % and 1.41 % for Rosuvastatin calcium and Bempedoic Acid respectively. The method is precise as the mean %RSD for Intraday studies of Rosuvastatin calcium and Bempedoic acid was 0.6064 % and 0.5289 % respectively while the Interday studies were 0.8763 % and 0.4955 % respectively. The LOD and LOQ for Rosuvastatin calcium are 0.054 µg/ml and 0.163 µg/ml and for Bempedoic acid are 0.127 µg/ml and 0.387 µg/ml respectively. Also, the method is robust as there was no significant change in result upon changing the method parameter. The developed method is environment friendly and is suitable for the quality control analysis of Rosuvastatin calcium and Bempedoic acid either alone or in combination.

Development and Validation of Analytical Method for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Sitagliptin Phosphate Monohydrate in Tablet Dosage Form

Development and Validation of Analytical Method for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Sitagliptin Phosphate Monohydrate in Tablet Dosage Form

Development of UV Method for Simultaneous Estimation of Imipramine and Ferulic Acid in Bulk and Developed Freeze-Dried Mixed Micelles

Introduction:: A simple, precise, and sensitive UV spectrophotometric method was developed to estimate Imipramine and Ferulic acid in bulk and polymeric micelles formulation. Moreover, imipramine and ferulic acid showed maximum absorbance at 237 nm and 216 nm. Methods: The method was validated for linearity, accuracy, precision, robustness, and ruggedness. The detector response for the imipramine and ferulic acid was linear over the selected range of 2 to 12 μg/ml with a correlation coefficient of 0.996 and 0.997. The accuracy was 99.4 and 101.02%. The precision (RSD) among six sample preparations was 0.68% and 0.85%. The method was validated as per the ICH guidelines. A polymeric micelle formulation was developed containing Vitamin E TPGS and F-127 as a surfactant and block co-polymer using different solvents. The optimized formulation containing 40 mg of F-127 and 30 mg of TPGS yielded the desired attributes of the optimized formulation. Results: The optimized formulation was subjected to freeze-drying and yielded nanoparticulate size and excellent flowability. In vitro, the release of both drugs from the polymeric micelles was evaluated using dissolution, and multi-fold enhancement in release behavior was demonstrated compared to pure drugs. Both drugs were simultaneously detected successfully with accuracy and precision in bulk form and during in vitro analysis Conclusion:: The developed method can be adopted in routine analysis of imipramine and ferulic acid in bulk, and it involves relatively low-cost solvents with no complex extraction techniques.