Pharmaceutica Analytica Acta

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

Received: 03-Jan-2020 Published: 27-Feb-2020, DOI: 10.35248/2153-2435.20.11.618

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].

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].

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 λ_max 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].

Table 1: Linearity Study of ASP at 276 nm.

Table 2: Linearity Study of OMZ at 301 nm.

Figure 3: Calibration Curve of Aspirin at 276 nm.

Figure 4: Calibration Curve of Omeprazole.

Figure 5: Overlay Spectra of ASP at 276 nm.

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).

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).

Table 4: Recovery Study.

Precision

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

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).

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).

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

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