ESTIMATION OF RABEPRAZOLE SODIUM IN TABLET DOSAGE FORM BY USING UV-VIS SPECTROPHOTOMETER

Abstract

The present invention relates to a UV-Visible spectrophotometric method for accurately estimating rabeprazole sodium in tablet dosage forms. The procedure involves preparing a standard stock solution and dissolving, sonicating, and diluting tablet samples for measurement. A calibration curve established within a linearity range of 2–10 µg/ml ensures accurate concentration readings. Validated according to ICH guidelines, the method demonstrates precision, accuracy, linearity, robustness, and sensitivity, with low limits of detection (LOD) and quantitation (LOQ) suitable for detecting small quantities. Minor condition changes do not affect results, confirming its robustness and adaptability in routine analysis. This method is cost-effective, eco-friendly, and applicable to quality control in pharmaceutical settings.

Specification

Description:FIELD OF INVENTION
The present invention relates to the field of pharmaceutical analysis, specifically the quantitative estimation of rabeprazole sodium in tablet dosage forms. This invention employs a UV-Visible spectrophotometric method for the accurate, simple, and cost-effective analysis of rabeprazole sodium concentration in pharmaceutical formulations.
BACKGROUND OF THE INVENTION
In pharmaceutical quality control and drug formulation, precise quantification of active ingredients, like rabeprazole sodium, is critical to ensure consistent efficacy and safety. Rabeprazole sodium, a proton pump inhibitor, is widely prescribed for acid-related disorders, making it essential to maintain its precise dosage in tablet form. Traditional methods for determining the concentration of rabeprazole sodium can be complex, time-consuming, and often require expensive, sophisticated equipment, which may not be feasible for smaller laboratories or low-resource settings.
Current methods, such as high-performance liquid chromatography (HPLC), although accurate, are costly and require specialized skills and maintenance, making them less practical for routine analysis in many pharmaceutical settings. This can create challenges in ensuring uniformity and reliability of rabeprazole dosage in production, potentially impacting product quality. Additionally, these methods may involve the use of organic solvents, which present both environmental and handling hazards, complicating waste disposal and increasing operational costs.
There is therefore a need for a simpler, cost-effective, and environmentally friendly approach to rabeprazole sodium quantification. By using UV-Visible spectrophotometry, the proposed invention addresses these issues by providing a method that is accessible, does not require extensive expertise, and reduces reliance on hazardous solvents. This invention offers a streamlined, efficient solution for pharmaceutical quality control, ensuring that rabeprazole sodium tablets meet regulatory standards without significant investment in costly analytical equipment.
OBJECTS OF THE INVENTION
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative
An object of the present disclosure is to provide a cost-effective method for rabeprazole sodium estimation in tablet forms.
Another object of the present disclosure is to reduces analysis time compared to conventional methods like HPLC.
Still another object of the present disclosure is to eliminates the need for expensive, sophisticated equipment.
Another object of the present disclosure is to uses UV-Vis spectrophotometry, which is widely available and easy to operate.
Still another object of the present disclosure is to minimizes the use of hazardous organic solvents, making it eco-friendly.
Still another object of the present disclosure is to requires less technical expertise, making it accessible for small labs.
Yet another object of the present disclosure is to ensures reliable and reproducible results for quality control.
Yet another object of the present disclosure is to supports routine analysis, enhancing production efficiency in pharmaceutical settings.
Yet another object of the present disclosure is to offers high sensitivity and accuracy for low-concentration measurements.
Yet another object of the present disclosure is to facilitates rapid quality assessment, aiding in faster decision-making for batch release.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY OF THE INVENTION
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.

The present invention is generally provides a UV-Visible spectrophotometric method for accurately quantifying rabeprazole sodium in tablet dosage forms, ensuring quality and consistency in pharmaceutical analysis.
An embodiment of the present invention is the standard stock solution of rabeprazole sodium is prepared at 100 µg/ml by dissolving the drug in 0.1 N HCl, with further dilutions used for analysis.
Another embodiment of the invention is tablets are powdered, dissolved, sonicated, diluted, and filtered, with the final sample concentration adjusted to 10 µg/ml for absorbance measurement
Yet another embodiment of the invention is a calibration curve is constructed for rabeprazole sodium within a linearity range of 2-10 µg/ml, ensuring accurate concentration measurement across this range.
Yet another embodiment of the invention is the developed method is validated for linearity, precision, accuracy, robustness, and sensitivity according to ICH guidelines, ensuring reliable performance.
Yet another embodiment of the invention is recovery studies are performed by adding known concentrations (80%, 100%, and 120%) of rabeprazole to the sample, confirming method accuracy.
Yet another embodiment of the invention is intra-day and inter-day precision studies are conducted, showing consistent results with low relative standard deviation values.
Yet another embodiment of the invention is the developed method shows robustness against minor variations and has low LOD and LOQ values, making it suitable for low-concentration measurements in diverse lab conditions.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig 1: Calibration curve of Rabeprazole Sodium.

DETAILED DESCRIPTION OF THE INVENTION
The following description is of exemplary embodiments only and is not intended to limit the scope, applicability or configuration of the invention in any way. Rather, the following description provides a convenient illustration for implementing exemplary embodiments of the invention. Various changes to the described embodiments may be made in the function and arrangement of the elements described without departing from the scope of the invention.
The present invention relates a reliable and cost-effective UV-Visible spectrophotometric method for the quantitative estimation of rabeprazole sodium in tablet dosage forms. The method begins with preparing a standard stock solution of rabeprazole sodium and follows with sample preparation involving tablet dissolution, sonication, and dilution. Utilizing a calibration curve with a linear range of 2-10 µg/ml, the method ensures accurate quantification. validation was performed following ICH guidelines, covering essential parameters like linearity, accuracy, precision, robustness, and sensitivity, confirming the method's reliability. The method's high sensitivity, low limits of detection (LOD) and quantification (LOQ), and robustness under minor condition variations make it adaptable for routine pharmaceutical analysis in diverse laboratory environments.
EXAMPLE 1: Preparation of Standard Stock Solution
To prepare the standard stock solution of rabeprazole sodium at a concentration of 100 µg/ml, 100 mg of rabeprazole sodium was accurately weighed and placed in a volumetric flask. It was then dissolved in approximately 75 ml of 0.1 N HCl, and the volume was adjusted to the 100 ml mark with 0.1 N HCl to complete the solution preparation. From this, 10 ml of the concentrated solution (1000 µg/ml) was further diluted to 100 ml with 0.1 N HCl, yielding the final stock solution of 100 µg/ml rabeprazole sodium. Table 1 shows the Calibration curve for rabeprazole sodium
Table:1 Calibration curve for rabeprazole sodium
S.no. Parameter (Units) Rabeprazole sodium

1 Linearity range (µg/ml) 2-10
2 Correlation coefficient (r2) 0.999
3 Slope 0.034
4 Intercept 0.012

EXAMPLE 2: Sample Preparation for Tablet Analysis
For the quantitative analysis of rabeprazole sodium in tablet dosage form, 20 PARIT-20 tablets were weighed, and a portion of the powder equivalent to 10 mg of rabeprazole sodium was transferred to a 100 ml volumetric flask. The powder was initially dissolved in 25 ml of 0.1 N HCl and sonicated for 10-15 minutes to ensure complete dissolution. The solution was then diluted to 100 ml with 0.1 N HCl and subsequently filtered. To obtain the final sample solution (10 µg/ml), a precise dilution was performed, and the absorbance was measured against a blank at 278 nm. The amount of rabeprazole sodium in the sample was calculated using an equation derived from the calibration curve.
Table: 2 Market formulation analysis
Formulation Drug Label claim (mg) %Amount found±S.D

Tablet Rabeprazole sodium 20mg 101.25±0.0025

EXAMPLE 3: Recovery Study for Method Accuracy:
To assess the accuracy of the developed spectroscopic method, a recovery study was conducted following International Council for Harmonisation (ICH) guidelines. This involved adding standard solutions of rabeprazole sodium to a pre-analyzed sample solution, with amounts equivalent to 80%, 100%, and 120% of the sample's drug content. Each concentration level was analyzed in replicates to ensure consistency and reliability of results. The recovery study confirmed the accuracy of the method by verifying that the measured amounts corresponded closely to the added concentrations.
EXAMPLE 4: Linearity
The linearity of the method was evaluated by constructing a calibration curve and performing a least squares linear regression analysis. The method demonstrated linearity over a concentration range of 2-10 µg/ml, with consistent results across this range, confirming that the method could accurately measure varying concentrations of rabeprazole sodium within the specified limits.
Results of linearity study of rabeprazole sodium was shown in table 3.
Table:3 Linearity study of rabeprazole sodium
Conc. µg/ml Dilution 1 Dilution 2 Dilution 3 Dilution 4 Dilution 5 Dilution 6 Mean±SD

2 0.0890 0.0868 0.0846 0.0753 0.0745 0.0752 0.0809±0.0066
4 0.1473 0.1485 0.1447 0.1485 0.1475 0.1495 0.1476±0.0016
6 0.2192 0.2211 0.2205 0.2175 0.2172 0.2156 0.2185±0.0021
8 0.2845 0.2842 0.2825 0.2839 0.2852 0.2867 0.2845±0.0013
10 0.3496 0.3542 0.3565 0.3521 0.3499 0.3512 0.3522±0.0026

EXAMPLE 5: Accuracy:
To assess the accuracy of the method, known amounts of rabeprazole sodium, equivalent to 80%, 100%, and 120% of the test preparation concentrations, were added to a placebo formulation. At each concentration level, three solutions were prepared and analyzed in duplicate to compare the actual versus measured concentrations. The accuracy study confirmed that the method could reliably quantify rabeprazole sodium even in the presence of other tablet excipients.
Results of the accuracy was shown in table 4. The accuracy data of the drug (Table 4) was shown good percentage recovery and %RSD with the range of 100.55 to 101.25 respectively.
EXAMPLE 6: Precision:
Precision was evaluated in terms of intra-day repeatability and inter-day (intermediate) precision. Intra-day precision was assessed by performing six independent assays on the test sample and calculating the relative standard deviation (RSD). Inter-day precision was further checked by replicating the analysis on different days under the same conditions by another analyst. This demonstrated that the method consistently produced reliable results regardless of the day or operator. Results of the precision was shown in table 4. The Inter-day and Intra-day(Table 4) precision values were found to be 98.85±0.0012 respectively, which indicates that the proposed method is accurate and also reveals that there is no interference of the commonly used excipients and additives in the formulation.
EXAMPLE 7: Limit of Detection (LOD) and Limit of Quantitation (LOQ)
The LOD and LOQ were calculated using standard deviation and slope-based equations. Specifically, the LOD was determined as three times the standard deviation divided by the slope, and the LOQ was ten times the standard deviation divided by the slope. These values confirmed the method's sensitivity for detecting and quantifying low levels of rabeprazole sodium, ensuring its suitability for precise and accurate measurements at minimal concentrations. Results of Limit of Detection (LOD) and Limit of Quantitation (LOQ) was shown in table 4.
EXAMPLE 8: Robustness:
The robustness of the method was tested by changing certain conditions, specifically using different UV analysts, while keeping other parameters constant (solvent, dilution, UV spectrophotometer settings). The method showed consistent results despite these slight variations, indicating its robustness and adaptability for routine use in diverse laboratory conditions. Results of robustness was shown in table 4.
Table:4 Validation parameter
S.no. Validation parameter Mean±S.D

1 Linarity 2-10µg/ml
2 Correlation coefficient r2 0.999
3 Slope 0.034
4 Intercept 0.012
5 Precision
Interday 1st day 100.40±0.0017
2nd day 99.66±0.0020
3rd day 99.66±0.0013
Intraday 1st hrs 98.91±0.0004
2nd hrs 101.89±0.0001
3rd hrs 100.54±0.0038
6 Recovery 80% 97.06±0.0005
100% 100.40±0.0001
120% 99.56±0.0001
7 LOD (mg/ml) 0.0290
8 LOQ (mg/ml) 0.0969
9 Robustness 100.10±0.0002
While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other changes in the preferred embodiment of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.
, Claims:1. A method for determining the concentration of rabeprazole sodium in a pharmaceutical tablet dosage form, comprising:
a) preparing a standard stock solution of rabeprazole sodium by dissolving a known amount of rabeprazole sodium in an acidic medium,
b) constructing a calibration curve by measuring absorbance at a wavelength of 278 nm,
c) preparing a test sample solution by dissolving an amount of the tablet equivalent to rabeprazole sodium in an acidic medium, sonicating, and filtering the solution,
d) measuring the absorbance of the sample solution and calculating the concentration of rabeprazole sodium based on the calibration curve.
2. The method as claimed in claim 1, wherein the acidic medium used for the standard stock solution and test sample solution is 0.1 N hydrochloric acid (HCl).
3. The method as claimed in claim 1, wherein the standard stock solution is prepared by dissolving 100 mg of rabeprazole sodium in 75 ml of 0.1 N HCl and diluting to a final concentration of 100 µg/ml.
4. The method as claimed in claim 1, further comprising a recovery study to validate accuracy, where standard solutions of rabeprazole sodium equivalent to 80%, 100%, and 120% of the sample's drug content are added and analyzed to confirm the method's reliability.
5. The method as claimed in claim 1, wherein the calibration curve is constructed for a linear concentration range of 2-10 µg/ml, showing a correlation coefficient (r²) of 0.999.
6. The method as claimed in claim 1, further comprising validation of the method's precision and robustness by conducting intra-day and inter-day repeatability tests and confirming consistent results across multiple conditions.
Dated this 8 November 2024

Dr. Amrish Chandra
Agent of the applicant
IN/PA No: 2959

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