Validation of UV spectrophotometric method for simultaneous estimation of vanillin and kaempferol in a binary mixture and pharmaceutical dosage form

Two methods for simultaneous estimation of Paracetamol and Pamabrom in combined tablet dosage form have been developed using Dist. water as a solvent. The first UV spectrophotometric method was a determination using the simultaneous equation method at 245.0 nm and 279.0 nm. The second UV spectrophotometric method is the Q – analysis (absorption ratio) method, which involves the formation of absorbance equation at 265.0 nm (iso absorptive point) and at 279.0 nm the maximum absorption of Pamabrom. The linearity ranges for Paracetamol and Pamabrom were 4-14 μg/ml and 2-12 μg/ml respectively. The accuracy of the methods was assessed by recovery studies was found to be 98.06%and 98.95 for simultaneous equation method and 98.65% and 99.54% for Q analysis (absorption ratio) method for Paracetamol and Pamabrom respectively. These methods are simple, accurate and rapid; those require no preliminary separation and can therefore be used for routine analysis of both drugs in quality control laboratories.

A simple, sensitive, accurate, precise and reproducible method has been developed for simultaneous estimation of Pregabalin and Etoricoxib in bulk and pharmaceutical dosage form (bilayer tablet). In the method, the methanol and phosphate buffer (pH 7.2) were used as solvent as the drugs could not be extracted from bilayer tablet with single organic solvent. Also, pregabalin is not having chromophore, so it does not show absorbance in UV range. So here the pregabalin was derivatized using ethanolic ninhydrin which shows absorption maximum at 576 nm. Etoricoxib shows the absorption maximum at 284 nm. Beer Lambert’s law was obeyed over a concentration range of 2-10 μg/ml for Pregabalin (r2 = 0.9991) & 4-24 μg/ml for Etoricoxib (r2 = 0.9998). The developed method was successfully applied for the estimation of Pregabalin and Etoricoxib in commercial product bilayer tablet. The assay was found to be 99.77 and 99.96 % for Pregabalin and Etoricoxib respectively. The developed method has been validated with respect to linearity, range, accuracy & precision. Also, the developed colorimetric method was extended for the estimation of Pregabalin using mobile phone/ smartphone application and was successfully used for the assay of pharmaceutical dosage form. Keywords: Pregabalin, Etoricoxib, Ninhydrin, UV spectrophotometric, Bilayer tablet, PhotoMetrix.

A simple, rapid, precise and highly selective spectrophotometric method was developed for simultaneous estimation of Hesperidin and Diosmin in tablet dosage form. This method, involves the measurement of absorbances of Hesperidin and Diosmin at the wavelengths of 285 nm (λmax of Hesperidin) and 268 nm (λmax, of Diosmin). The UV spectra’s of Hesperidin and Diosmin prepared in different solvents water, methanol, and acetonitrile and 0.2 N sodium hydroxide were recorded. These two drugs showed good absorbances when dissolved in 0.2 N NaOH. Hence 0.2 N NaOH was selected as the solvent for the method. Two wavelengths 285 and 268 nm were selected which are λmax of two drugs Hesperidin and Diosmin, respectively. Different concentrations of Hesperidin (5–50 μg/mL) and Diosmin (2–24 μg/mL) and a mixture of Hesperidin and Diosmin were prepared, scanned and absorbances were noted at the two wavelengths were fixed for the study. The method showed good reproducibility and recovery with % RSD less than 2. The LOD of Hesperidin and Diosmin was found to be 0.139 μg/mL and 0.048 μg/ml and LOQ of Hesperidin and Diosmin was found to be 0.42 μg/mL and 0.147 μg/mL, respectively. Thus the proposed method was found to be rapid, specific, precise, accurate and cost effective quality control tool for the routine analysis of Hesperidin and Diosmin in bulk and combined dosage form.

The result of pharmaceutical industry research for the new class and the new combination of drugs for the treatments of diabetes is the newly approved combination of Remogliflozin etabonate (RGE) and Teneligliptin Hydrobromide hydrate (TG). For the quality control of this formulation, the smart, reproducible and non-sophisticated spectroscopic techniques were developed by modification of UV spectra. The proposed methods exhibited Beer’s law in the range of 10 to 60µg/ml and 5 to 30µg/ml for RGE and TG correspondingly. The mean percentage recovery was found to be in the range of 98.60 to 101.55 for RGE and 99.87 to 100.21 for TG. Further, both analytes were quantified from the formulation using proposed spectroscopic methods with high accuracy. The suggested technique is simple, accurate and reproducible, hence could be used for regular quality control of formulation consisting of RGE and TG. The developed method can be used for analysis of stability samples and routing quality control evaluation in tablet formulation.

Development and validation of UV Spectrophotometric method for simultaneous estimation of Lamivudine and Efavirenz in the Pharmaceutical dosage form

Validation and application of Vierordt's spectrophotometric method for simultaneous estimation of tamoxifen/coenzyme Q10 in their binary mixture and pharmaceutical dosage forms

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.

The present study describes simple, specific, sensitive, rapid and economical U.V. spectrophotometric methods for simultaneous estimation of amlodipine besylate and theophylline. The absorbance maxima of the drug were found to be239 nm and 272 nm respectively. Method I is based on formation and solving of simultaneous equation known as Vierodt's method. Method II is based on principle of Q-analysis known as absorbance ratio method. Beer's law obeyed in concentration range of 5–30 μg/ml having regression line equation y = 0.041x + 0.017 and y = 0.064x + 0.052 with correlation coefficient 0.999 and.0.997 of amlodipine besylate and theophylline respectively. Different parameter such as linearity, precision, LOD and LOQ, slope and standard deviation were used for validation in both method.

Objective: A new, simple, rapid, accurate and economical method have been developed for the simultaneous estimation of Metformin HCl and Repaglinide in formulation. Method: The absorbances of both the drugs were determined at 238 nm and at 294 nm. The linearity was observed in the concentration range of 2-100 µg/ml and 1-35 µg/ml for Metformin HCl and Repaglinide respectively. The method was validated as per ICH guidelines. Result: The recovery of Metformin and Repaglinide was found in the range of 98.24 ± 0.325 to 100.25 ± 0.756. Conclusion: The proposed method was accurate, reproducible and economical and can be used successfully for quantitative estimation of Metformin HCl and Repaglinide in bulk and tablet dosage form. Keyword:- Metformin, Repaglinide, UV- spectrophotometric method, simultaneous estimation

A simple, specific, sensitive, rapid, precise, accurate and economical UV Spectrophotometric simultaneous equation method have been developed and validated for the routine estimation of Dolutegravir sodium and Rilpivirine Hydrochloride in bulk form. The Method A employs estimation of drugs by simultaneous equation method (SEM) using synthetic mixture of drugs. The absorption maxima of drugs were found to be at 259.20nm for Dolutegravir sodium and 305.80nm for Rilpivirine Hydrochloride. Both drugs followed the beer lamberts law in the range of 4-24µg/ml and 1-8µg/ml for DOL and RIL respectively. Methods are validated according to ICH guidelines and can be adopted for the routine analysis Dolutegravir sodium and Rilpivirine Hydrochloride in pure bulk form.

Two UV spectrophotometric methods have been developed for accurately analyzing Lobeglitazone Sulfate and Glimepiride in combined dosage form, used in the treatment of type 2 diabetes mellitus. Method I, known as the simultaneous equation method (Vierodt’s Method), relies on measuring the absorption at 250 nm for Lobeglitazone Sulfate and 227 nm for Glimepiride, their respective λmax values. Method II involves the second-order derivative method, where the absorbance of Lobeglitazone Sulfate is measured at 297 nm (zero-crossing point of Glimepiride), and that of Glimepiride is measured at 259 nm (zero-crossing point of Lobeglitazone Sulfate). Both methods exhibit linearity within specified concentration ranges: 3-13 μg/mL for Lobeglitazone Sulfate and 6-26 μg/mL for Glimepiride, using methanol as the solvent. The accuracy of these methods was confirmed through recovery studies, yielding results within the range of 98-102% for both drugs. Precision was evaluated through repeatability and intermediate precision studies, demonstrating % RSD values below 2%, indicating high precision. A comparison between the two methods using the F-test showed no significant difference. Statistical validation according to ICH Q2 R1 guideline confirmed the reliability of the results obtained from both methods.

Efonidipine Hydrochloride Ethanolate and Chlorthalidone is used in management of hypertension and under clinical phase 3 study. The development of quality control method is required for accurate analysis of both drugs. Two simple, precise and economical UV spectrophotometric methods have been developed for the simultaneous estimation of Efonidipine Hydrochloride Ethanolate and Chlorthalidone in their synthetic mixture. Method I is simultaneous equation method (Vierodt’s Method), which is based on measurement of absorption at 251 and 227 nm i.e. λmax of Efonidipine Hydrochloride Ethanolate and Chlorthalidone, respectively. Method II is first order derivative was based on the measurement of absorbance of Efonidipine Hydrochloride Ethanolate measure at 283.2 nm (ZCP of Chlorthalidone) and absorbance of Chlorthalidone measure at 250.8 nm (ZCP of Efonidipine Hydrochloride Ethanolate). Linearity was observed in the concentration range of 6.4-38.4 µg.mL-1 for Efonidipine hydrochloride ethanolate and 2-12 µg.mL-1 for Chlorthalidone using methanol as a solvent. The accuracy of methods was assessed by recovery studies and was found to be within range of 98-102% for both the drugs. Precision of the methods was estimated by repeatability and intermediate precision studies. The % RSD values were found to be less than 2, proving methods were precise. Two methods were compared using F- test. The results were validated statistically as per ICH Q2 R1 guideline and were found to be satisfactory.

A simple, rapid and precise spectrophotometric method has been developed for simultaneous estimation of Metformin and Glipizide. The method involved estimation of Metformin and Glipizide by simultaneous equation at 272nm and 232nm respectively in their solution in water. This method was validated with respect to linearity, accuracy, precision, LOD and LOQ. Beer’s law obeyed in the concentration range of 5-25μg/ml and 20-50μg/ml for Metformin and Glipizide respectively with the correlation coefficient of above 0.99. Limit of detection and quantification values were determined to be 0.214μg/ml and 0.649μg/ml for Metformin and 0.608μg/ml and 1.854μg/ml for Glipizide respectively. Mean recovery of Metformin and Glipizide were found to be in the range of 98-102% signifies the accuracy of the method. The method was found to be precise as %RSD was less than 2.

A sensitive and specific spectrophotometric method has been developed for the simultaneous determination of nitrate and nitrite at trace levels. The proposed method is based on diazotization of nitrite with a pharmaceutical compound-metoclopramide (4-amino-5-chloro- N -(2-(diethylamino)ethyl)- 2-methoxybenzamide) in acid medium to form diazonium ion which is coupled with ethyl acetoacetate (EAA) in basic medium to form azo dye, showing absorption maxima at 437.5 nm. Different variables affecting the reactions are optimized. The method is precise and accurate and has been applied to water, soil, drug and vegetable samples. The results of the investigated method using metoclopramide were compared with available official literature method. The results obtained by the proposed method agree well with the standard established method. Keywords : Diazotization, Nitrate and Nitrite, Spectrophotometric Estimation.

Development and Validation of UV Spectrophotometric Methods for Simultaneous Estimation of Rosuvastatin and Telmisartan in Pure and Tablet Dosage Form