Pharmaceutica Analytica Acta

Pharmaceutica Analytica Acta
Open Access

ISSN: 2153-2435

+44 1202068036

Research Article - (2020) Volume 11, Issue 1

Development and validation of UV Spectrophotometric method for simultaneous equation of Aspirin and Omeprazole in tablet dosage form

Sandip S Chaudhari* and Swapnil D Phalak
 
*Correspondence: Sandip S Chaudhari, TVES’s HLMC College of Pharmacy, Faizpur, Maharashtra, India, Tel: 9922246400, Email:

Author info »

Abstract

YOSPRALA is newly designed tablet which effective in cardiovascular as well as gastrointestinal protection due to its immediate release of Omeprazole (40 mg) and delayed release of Aspirin (81 mg) or (325 mg) dose strength. Yosprala was approved by USFDA in Sept 2016 for cardiovascular and cerebrovascular diseases.

Aspirin is an antiplatelet agent & Omeprazole is proton pump inhibitor therefore it is made to develop a new analytical method for Simultaneous estimation of Aspirin and Omeprazole using Mehtanol as a solvent on the basis of solubility. The maximum Absorption (λ max) of Aspirin and Omeprazole was found at 276 and 301 respectively. Linearity range for aspirin was given at 10-50 μg/ml with %RSD value 0.997 and Omeprazole was 2-10 μg/ml with %RSD value 0.997. The method was validated for precision and % RSD was found less than 2.0 for both aspirin and omeprazole. The proposed method was statistically validated for standard deviation, relative standard deviation, coefficient of variance and the results were within the range. Hence the above method was simple, cheap, cost effective, economical, and robust.

Keywords

Yosprala; Aspirin; Omeprazole; UV spectroscopy; λ max

Introduction

Aspirin is an antipletelet agent while omeprazole is proton pump inhibitor used in combination for treatment of stroke and other cardiovascular disease. On extensive literature survey it was found that very few methods are reported for Simultaneous estimation of Aspirin and Omeprazole in combined dosage form by any analytical technique. These methods were developed on single Aspirin only or combination with other drugs by using UV spectroscopy in tablet dosage form, hence i was decided to develop a new method which having accurate, precise, economical, rapid and cost effective (Figure 1) [1].

pharmaceutica-analytica-acta-aspirin

Figure 1: Aspirin.

Aspirin [2-(acetyloxy) benzoic acid], acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. It also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis (Figure 2) [2].

pharmaceutica-analytica-acta-omeprazole

Figure 2: Omeprazole.

Omeprazole is a proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease (PUD), Gastro esophageal reflux disease (GORD/GERD), Laryngopharyngeal reflux (LPR) and Zollinger–Ellison syndrome.

Omeprazole is entirely metabolised by the hepatic cytochrome P-450 system (CYP), mainly in the liver. Identified metabolites in plasma are the sulfone, the sulfide and hydroxyomeprazole [3].

Simultaneous equation method is used where a sample contains two absorbing drugs (X and Y) each of this absorbance λmax of each other, it may be possible to determine both the drugs by the technique of simultaneous equation method.

Materials and Methods

Chemicals and reagents

The bulk drug of pure Aspirin powder was obtained from Alta laboratories, Mumbai and Omeprazole from Blue Cross Laboratories, Nasik. Yosprala tablets were procured from local market. All chemicals and reagents of analytical grade were purchase from Merck Chemical, Mumbai, INDIA

Instrument

A double beam Shimadzu UV-visible spectrophotometer model 1800 with UV probe software was used for absorption measurements.

Solubility

As per solubility studies it was found that both the drug sample are freely soluble in methanol.

Determination of λ max of individual component

An appropriate aliquot portion of ASP (0.5 mL) and OMZ (0.1 mL) were transferred to two separate 10 mL volumetric flasks, the volume was made up to the mark using 80% v/v methanol to obtain ASP (50 μg/mL) and OMZ (10 μg/mL). Drug solutions were scanned separately between 200 nm to 400 nm [4].

The overlain spectrum of both drugs having concentrations 130 μg/ mL ASP and 16 μg/mL OMZ was recorded and two wavelengths 276.0 nm (λ max of ASP) and 301.0 nm (λ max of OMZ) were selected for further study [5].

Preparation of standard stock solutions of ASP and OMZ

A) Aspirin standard stock solution [A]: An accurately weighed quantity of ASP (10 mg) was taken in 10 mL volumetric flask and dissolved in methanol (8 mL) with the help of ultrasonication for about 10 min. Then the volume was made up to the mark using methanol to get Aspirin standard stock solution (1 mg / mL) [6].

B) Omeprazole standard stock solution [O]: An accurately weighed quantity of OMZ (10 mg) was taken in 10 mL volumetric flask and dissolved in methanol (8 mL) with the help of ultrasonication for about 10 min. Then the volume was made up to the mark using methanol to get Omeprazole standard stock solution (1 mg / mL) (Tables 1, 2 and Figures 3-6) [7-9].

Sr. No. Concentration of ASP in [µg/mL] Absorbance Mean ± S.D. [n=5] % R.S.D.
1 10 0.073 ± 0.0008 1.142
2 20 0.112 ± 0.0007 0.631
3 30 0.165 ± 0.0018 1.133
4 40 0.212 ± 0.0011 0.536
5 50 0.265 ± 0.0008 0.315

Table 1: Linearity Study of ASP at 276 nm.

Sr. No. Concentration of OMZ in[µg/mL] Absorbance Mean ± S.D. [n=5] % R.S.D.
1 2 0.0588 ± 0.0018 1.117
2 4 0.1052 ± 0.0019 1.828
3 6 0.1622 ± 0.0014 0.914
4 8 0.225 ± 0.0012 0.544
5 10 0.2744 ± 0.0018 0.662

Table 2: Linearity Study of OMZ at 301 nm.

pharmaceutica-analytica-acta-calibration-curve

Figure 3: Calibration Curve of Aspirin at 276 nm.

pharmaceutica-analytica-acta

Figure 4: Calibration Curve of Omeprazole.

pharmaceutica-analytica-acta-overlay-spectra

Figure 5: Overlay Spectra of ASP at 276 nm.

pharmaceutica-analytica-acta

Figure 6: Overlay Spectra of OMZ at 301 nm.

Results and Discussion

Results of Standard Laboratory Mixture (API) and YOSPRALA Tablet by UV- Spectroscopic methods (Table 3).

Sr. No Sample Statistical data %Label Claim
ASP OMZ
1. Standard Laboratory Mixture (API) Mean 99.85 99.80
S.D. 0.0764 0.0697
% R.S.D 0.0766 0.0699
2. YOSPRALA Tablet Mean 99.87 99.85
S.D. 0.0702 0.0465
% R.S.D 0.0703 0.0466

Table 3: Summary of Results for UV-spectroscopic methods.

Validation of proposed method

The Proposed method was validated as per the ICH guidelines.

Accuracy [recovery study]

Accuracy of proposed method was ascertained on the basis of recovery study performed by standard addition method (Table 4).

Sr. No. Quantity
Tablet
Powder
Taken
Percentage % Amount of Pure Drug Added (mg) Total Amount of Drug Recovered (mg) ± S.D. (n=3) % of Drug Recovered (n=3)
ASP OMZ ASP OMZ ASP OMZ
1. 478 80 260 32 583.3 ± 1.08 71.64 ± 0.06 99.70 99.50
2. 478 100 325 40 649.6 ± 1.17 79.91 ± 0.05 99.95 99.88
3. 478 120 390 48 714.7 ± 1.43 87.95 ± 0.02 99.90 99.94
  Mean 99.85 99.77
SD 0.1322 0.2386
% RSD 0.1324 0.2388

Table 4: Recovery Study.

Precision

According to ICH guidelines acceptance criteria for precision the %RSD should NMT 2% (Table 5).

  Conc. [µg/mL] Intra-day Amount Found Inter-day Amount Found
Mean ±S.D [n=5] % R.S.D. Mean ± S.D. [n=5] % R.S.D.
ASP 10 9.94 ± 0.064 0.6462 9.92 ± 0.1013 1.0213
20 19.89 ± 0.1814 0.9121 19.86 ± 0.2309 1.1622
30 29.79 ± 0.272 0.9156 29.75 ± 0.3614 1.2147
OMZ 2 1.97 ± 0.081 0.5452 1.95 ± 0.0151 0.7753
4 3.92 ± 0.0336 0.856 3.91 ± 0.0420 1.0737
6 5.87 ± 0.0342 0.5819 5.83 ± 0.0707 1.2128

Table 5: Precision study.

Ruggedness

LOD: Limit of detection of Aspirin and Omeprazole were found to be 0.2528 μg/mL and 0.2307 μg /mL respectively (Table 6).

  ASP 325 µg/mL OMZ 40 µg/mL
  Parameters Amount Found in µg/mL Mean ± S.D. (n=3) % RSD Amount Found in µg/mL Mean ± S.D.(n=3) % RSD
Analyst I 324.46± 0.3614 0.1113 39.78 ± 0.1484 0.3730
Analyst II 324.95 ± 0.3968 0.1221 39.82 ± 0.1569 0.3940
Day-I 324.29 ± 0.6340 0.1955 39.77 ± 0.1861 0.4678
Day-II 325.06 ± 0.6562 0.2019 39.80 ± 0.1908 0.4795
Instrument I 324.21 ± 0.7379 0.2276 39.73 ± 0.2753 0.6930
Instrument II 324.89 ± 0.8580 0.2641 39.70 ± 0.2662 0.6707

Table 6: Ruggedness study.

LOQ: Limit of Quantitation of Aspirin and Omeprazole were found to be 1.766 μg/mL and 1.954 μg/mL respectively.

System suitability parameters

The following parameters are system suitability parameters for the analytical method developed according to ICH guidelines (Table 7).

Sr.no Parameters Aspirin Omeprazole
1 λmax 276 nm 301 nm
2 Regression co-efficient (r2) 0.997 0.997
3 LOD (μg/ml) 0.2528 0.2307
4 LOQ (μg/ml) 1.766 1.954
5 Linearity range 10-50 μg/ml 2-10 μg/ml

Table 7: System suitability parameters.

Conclusion

It was through to develop an analytical method for simultaneous equation method for estimation of Aspirin and Omeprazole by using UV Spectroscopy. The developed method was validated for linearity, Accuracy, precision, ruggedness and results were within the limits according to ICH guidelines. The proposed method was cost effective, simple, rapid, economic, cheap, precise and robust. The above method can be used for routine analysis of Aspirin and Omeprazole in bulk and Tablet Dosage Form

Acknowledgment

The author’s were thankful to Principle of TVES’s HLMC College of Pharmacy, Faizpur (MS) INDIA for providing necessary help for work.

References

Author Info

Sandip S Chaudhari* and Swapnil D Phalak
 
TVES’s HLMC College of Pharmacy, Maharashtra, India
 

Citation: Chaudhari SS, Phalak SD (2020) Development and Validation of UV Spectrophotometric Method for Simultaneous Equation of Aspirin and Omeprazole in Tablet Dosage Form. Pharm Anal Acta 11:618. doi: 10.35248/2153-2435.20.11.618

Received Date: Jan 03, 2020 / Accepted Date: Feb 20, 2020 / Published Date: Feb 27, 2020

Copyright: © 2020 Chaudhari SS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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