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Journal of Drug Delivery and Therapeutics

Open Access to Pharmaceutical and Medical Research

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Open Access Full Text Article   Research Article

Development of UV Spectrophotometric Method and Estimation of Simvastatin in Tablet Formulation

Pooja Harkal , Pravin Wakte , Sachin Bhusari * 

University Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar, India

 

 

Simvastatin, marketed under the brand name Zocor, is a cholesterol-lowering medication that is produced through the chemical modification of compounds obtained from the fermentation of Aspergillus terreus. Simvastatin is a member of the statin drug class, which functions as an inhibitor of the enzyme HMG-CoA reductase. The pharmaceutical agent, a synthetic derivative originating from compounds produced by Aspergillus terreus fermentation, is primarily utilized for managing dyslipidemia and preventing cardiovascular disorders. Chemically, simvastatin is a lactone prodrug that, upon hydrolysis, undergoes hydrolysis to yield its active β-hydroxyacid metabolite. This active form effectively restricts the activity of HMG-CoA reductase—the crucial enzyme driving the conversion of HMG-CoA to mevalonate, a key early phase in hepatic cholesterol synthesis. ^1-6

By inhibiting the cholesterol biosynthetic pathway, simvastatin decreases endogenous cholesterol production, resulting in reduced low-density lipoprotein (LDL) levels in the circulation. While a variety of analytical approaches, such as HPLC, GC, UPLC-MS/MS, LC-MS/MS, and UV-spectrophotometric techniques, are available for quantifying simvastatin, the study focused on designing a straightforward, reliable, and cost-effective UV spectrophotometric technique for its estimation in both pure substance and tablet formulations. ^7-22

Formula: C₂₅ H₃₈ O₅

Molecular Weight: 418.566 g/mol.

 

 

Figure 1: Chemical structure of Simvastatin 

2.1 Chemicals and reagents

The API sample of Simvastatin was procured from Cipla, India. Analytical Grade methanol and water were used. The marketed formulation of simvastatin tablets was purchased from the local market.

2.2 Instrumentation

UV analysis was carried out using a Jasco V 530 UV Double Beam Spectrophotometer and Jasco V 530 Software. Quartz cuvettes (1cm) matched pair quartz cell. Morter and Pestle for crushing the tablets were used. PCi ANALYTICS were used for sonication for dissolving tablet and also centrifuge for separation of dissolved and poorly dissolved powder of tablets.

2.3 Solubility study of the drug

10 mg simvastatin was weighed, and the solubility was observed in 10 ml of water, methanol, 0.1N NaOH, and HCl. By observing the formed solution, the drug is freely soluble in methanol and practically poorly soluble in other solvents. Hence, methanol was selected as a solvent.

2.4.1 Preparation of stock solution

A primary stock solution of Simvastatin was accurately prepared by weighing 10 mg of the analyte and dissolving it in 10 mL of HPLC-grade methanol, yielding a concentration of 1000 µg/mL. 

2.4.2 Preparation of standard solution

Subsequently, a 1 mL aliquot of the stock solution was quantitatively transferred into a 10 mL volumetric flask and diluted to volume with a methanol–water mixture (50:50 v/v), resulting in a working standard solution with a final concentration of 100 µg/m.

2.5 Determination of the wavelength of maximum absorption

A 10 μg/mL standard solution was analyzed using UV-Vis spectroscopy across the 200–400 nm range, with a blank as the reference, to determine the wavelength of maximum absorption.

 

 

 

Figure 2: Spectra of Simvastatin at 238nm

 

 

The spectra in Figure 2 indicate that the λmax for quantifying Simvastatin is 238.0 nm.

2.6 VALIDATION

The developed UV spectrophotometric method was rigorously validated according to ICH guidelines, evaluating critical parameters such as linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ), to ensure its suitability for accurate and reliable determination of Simvastatin in both bulk drug substance and tablet dosage forms.

 

 

2.6.1 Linearity

The ability of an analytical method to produce results directly proportional to analyte concentration within a specified range. Serial dilutions were carried out from the standard solution to achieve concentrations of 1μg/mL, 2μg/mL, 6μg/mL, 8μg/mL, 12μg/mL, 16μg/mL, and 20μg/mL. The absorbance for each concentration was recorded at a wavelength of 238 nm. A calibration curve was constructed by plotting absorbance values on the Y-axis against their corresponding analyte concentrations on the X-axis, enabling quantification of unknown samples based on the established linear relationship. ^23-25

2.6.2. Precision

The closeness of agreement between repeated measurements of the same standardized sample under specified conditions. The precision of the analytical method was assessed by evaluating both repeatability (intra-day precision) and intermediate precision (inter-day precision) using a standard solution. Six replicate absorbance measurements were recorded from a homogeneous solution under the same experimental conditions. The variability of the results was quantified by calculating the relative standard deviation (%RSD), and the precision was expressed as the %RSD for each level of evaluation.

2.6.3 Accuracy

The accuracy of an analytical method represents the degree of agreement between the measured values and the true value. Accuracy assessment is conducted at three concentration levels—80%, 100%, and 120%—by fortifying the sample with a precisely quantified amount of the reference standard. Each concentration level is analyzed in triplicate to evaluate the method’s reliability in producing quantitative results comparable to the actual concentration present. ^(26-28)

2.6.4 Limit of Detection (LOD)

The Limit of Detection (LOD) is the lowest analyte concentration in a sample that can be reliably differentiated from the background noise. However, it may not be quantified with acceptable accuracy or precision under the specified experimental conditions. Typically, the corresponds to a signal-to-noise ratio of approximately 3:1. In accordance with the International Council for Harmonisation (ICH) guidelines, the LOD can be calculated using the expression:

  

where:

• σ represents the standard deviation of the response, determined either from the standard deviation of the regression residuals or from replicate measurements of the blank.
• S denotes the slope of the calibration curve.

2.6.5 Limit of Quantification (LOQ) 

The Limit of Quantification (LOQ) is the lowest concentration at which the analyte can be quantified with acceptable levels of accuracy and precision. It is conventionally associated with a signal-to-noise ratio of about 10:1, ensuring the reliability and reproducibility of quantitative results.

LOQ is calculated as:

 

where σ and S carry the same definitions as indicated above.

This approach ensures that both LOD and LOQ are determined based on the calibration curve characteristics and the variability inherent in the analytical method, thereby providing robust sensitivity parameters for method validation. ^(27,29,30)

Robustness of an analytical method denotes its capability to deliver consistent performance despite minor, intentional variations in procedural parameters, thereby confirming its reliability under standard operational conditions. This evaluation assessed robustness by modifying the λmax by ±2 nm for a 10 µg/ml solution, with each assessment performed in triplicate.

The ruggedness of the analytical method was assessed by performing the analysis on different days, with multiple analysts, and employing reagents and instruments from various manufacturers to evaluate its reproducibility under variable conditions. ^27,31,32

3. RESULTS AND DISCUSSIONS

3.1. Linearity and Range

The obtained calibration curve was evaluated using its correlation coefficient. The absorbance for each concentration was measured at 238 nm. The absorbance of the samples in the range of 1–20 mg/mL was linear, with a correlation coefficient (R2) greater than 0.999, as indicated by the least-squares regression equation y = 0.0555x + 0.0232. The LOD and LOQ were calculated as 0.11406 mg/mL and 0.34565 mg/mL, respectively. A calibration curve was constructed by plotting absorbance values on the Y-axis against analyte concentrations on the X-axis, enabling quantification of unknown samples based on the established linear relationship.

Figure 3: Calibration curve of Simvastatin

 

 

Table 1: Calibration curve data of Simvastatin

 

 

3.2 Accuracy

Accuracy of the UV–visible spectrophotometric method for simvastatin was assessed using standard addition recovery studies across the full calibration range, ensuring reliability of results at all concentration levels. Recovery experiments were performed at 80%, 100%, and 120% of the nominal concentration. The mean percentage recoveries obtained were 97.7502%, 105.787%, and 100.94%, respectively, with corresponding %RSD values of 2.616, 0.767, and 1.644 (Table 2). All recovery values were within the generally accepted range of 95–105%, confirming that the developed method achieves a high degree of accuracy for the quantitative determination of simvastatin in the tested matrix.

 

 

Table 2: Accuracy data of UV method for Simvastatin

Concentration µg/ml	Nominal Concentration	Mean measure Concentration	% Difference	% Recovery	Mean recovery	%RSD
80	1.5	1.45757	2.91993	97.1713	97.7502	2.6164
80	1.5	1.47639	1.62615	98.4259
80	1.5	1.4648	2.40435	97.6533
100	10	10.5907	-5.5769	105.907	105.787	0.767
100	10	10.5439	-5.1562	105.439
100	10	10.6015	-5.6733	106.015
120	19	19.0218	-0.1102	100.115	100.94	1.644
120	19	19.108	-0.565	100.568
120	19	19.406	-2.0881	102.137

 

 

3.3 Precision

Precision of the analytical method was assessed at three levels: repeatability, intraday precision, and interday precision. Precision was quantified using standard deviation as a measure of variability. For repeatability, six standard solutions each at 10 µg/ml were prepared, and their absorbance was recorded at 238 nm across three concentration levels. The percentage relative standard deviation (% RSD) was then calculated (Table 3). Intraday precision was evaluated by preparing nine solutions at concentrations of 1.5, 10, and 19 µg/ml, each measured in triplicate. 

 

 

Interday -

	Morning			Afternoon			Evening
Reading	Average	SD	%RSD	Average	SD	%RSD	Average	SD	%RSD
1.5	1.4711	0.0258	1.7609648	1.45237727	0.0275	1.8935256	1.47	0.06	3.79
10	10.563	0.0694	0.6568409	10.597706	0.101	0.9538428	10.58	0.08	0.72
19	18.899	0.2131	1.127785	19.08998	0.1633	0.8558022	19.53	0.1	0.51

Intraday -

Table 3: Precision data (Interday and Intraday) UV method for Simvastatin

	Day 1			Day 2			Day 3
Reading	Average	SD	%RSD	Average	SD	%RSD	Average	SD	%RSD
1.5	1.444	0.0191	1.32583	1.5004	0.0355	2.36564	1.4596	0.0238	1.63251
10	10.618	0.0581	0.54736	10.494	0.0571	0.54404	10.623	0.0509	0.47939
19	19.145	0.2794	1.45957	19.132	0.3022	1.57971	19.282	0.3816	1.97907

 

 

Limit of Quantitation (LOQ) is the lowest concentration of an analyte that can be quantitatively measured with acceptable accuracy and precision, and it generally corresponds to the lowest point on the calibration curve. For the proposed UV–visible spectrophotometric method, the Limit of Detection (LOD) and Limit of Quantitation (LOQ) were determined to be 0.11406 µg/mL and 0.34565 µg/mL, respectively as shown in Table. The low LOQ indicates that the method has sufficient sensitivity to accurately quantify simvastatin even at trace concentrations in the sample. 

 

 

Table 4: LOD and LOQ data of UV method for Simvastatin

 

 

Robustness refers to the ability of an analytical method to maintain its performance despite small, deliberate variations in experimental conditions. This parameter is important because minor, unintentional changes in factors such as solvent composition, buffer strength, or pH can occur during routine analysis and may potentially affect method reliability. For the proposed UV–visible spectrophotometric method, robustness was assessed by varying the solvent composition. Changing the methanol: water ratio from 52:48 to 48:52 produced no significant change in analytical performance, confirming that the method is robust under these tested conditions.

 

 

Table 5: Methanol: Water (48:52) ratio data of UV method for Simvastatin

	1.5		10		19
Sr. no.	LQC	Amount	MQC	Amount	HQC	Amount
1	0.103	1.556313993	0.616	10.3105802	1.1298	19.078
2	0.1064	1.614334471	0.6265	10.4897611	1.117	18.86
3	0.1003	1.510238908	0.6192	10.3651877	1.1104	18.747

 

Table 6: Methanol: Water (52:48) ratio data of UV method for Simvastatin

	1.5		10		19
Sr. no.	LQC	Amount	MQC	Amount	HQC	Amount
1	0.102	1.539249147	0.626	10.4812287	1.1163	18.848
2	0.1035	1.564846416	0.6188	10.3583618	1.1149	18.824
3	0.1033	1.561433447	0.6276	10.5085324	1.1188	18.891

 

 

 

 

 

Ruggedness is defined as the ability of an analytical method to consistently produce accurate and precise results despite deliberate or unintentional variations in external or environmental conditions, such as changes in temperature, instrumentation, analysts, or laboratory location. Methods with high ruggedness are preferred because they remain unaffected by such factors, ensuring reproducibility across different settings. The ruggedness of the proposed UV–visible spectrophotometric method for simvastatin was assessed by analyzing simvastatin dilutions using two different UV–visible spectrophotometers located in separate laboratories. The comparable results obtained from both instruments confirmed that the method is rugged and reliable under varying operational conditions.

 

 

Table 7: Ruggedness data of UV method for Simvastatin

Sr. No.	Concentration (µg/mL)	Make and Model of instrument	Conc. (µg/mL)	% RSD
1	10	Jasco, V 530	0.6250932	1.0839
2	10	Perkin Elmer, Lambda 25	0.615933	0.167048

 

 

3.7 Assay of tablet formulation

Three tablets each of SIMVOTIN® 20 mg and SIMVOTIN® 10 mg (Sun Pharmaceutical Industries Ltd., India) were accurately weighed and powdered separately. From each batch, an amount of powder equivalent to 10 mg of simvastatin was accurately weighed, finely triturated in a mortar and pestle, and transferred to a beaker containing pure methanol. The mixture was vortex-mixed, sonicated, and centrifuged to obtain a clear supernatant, which was transferred to a 10 mL volumetric flask and diluted to volume with methanol, yielding a stock solution of 1000 µg/mL. From the stock, an aliquot was diluted with methanol: water (50:50, v/v) to obtain a 100 µg/mL intermediate solution, which was further diluted to 10 µg/mL for analysis. The entire procedure was performed separately for the 20 mg and 10 mg tablet formulations, each using three tablets.

 

 

Percent Assay =     × 100

 

Sr. No.	Label claim (mg)	Tablet solution containing Simvastatin(µg/ml)	% Found	Mean % Found	% RSD
T1	20	10	99.3368	99.6742	1.13768523
T2	20	10	101.657
T3	20	10	99.7731
T4	10	10	99.4415
T5	10	10	98.151
T6	10	10	99.6858

 

 

CONCLUSION

A simple, accurate, and precise UV–Visible spectrophotometric method for the quantitative estimation of Simvastatin was developed and validated in accordance with ICH guidelines. The method exhibited robustness and ruggedness, confirming its reliability for routine analytical determination.

Conflict of Interest: The authors declare no potential conflict of interest concerning the contents, authorship, and/or publication of this article.

Author Contributions: All authors have equal contributions in the preparation of the manuscript and compilation.

Source of Support: Nil

Funding: The authors declared that this study has received no financial support.

Informed Consent Statement: Not applicable. 

Data Availability Statement: The data presented in this study are available on request from the corresponding author. 

Ethical approval: Not applicable.

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