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Development of UV Spectrophotometry and RP-HPLC Methods for the Estimation of Levosulpiride in Bulk and in Tablet Formulation


Affiliations
1 Axis Clinicals Ltd, Hyderabad, Andhra Pradesh, India
2 Dept. of Pharmaceutical Analysis, Adhiparasakthi College of Pharmacy, Melmaruvathur-603319, Tamilnadu, India
3 Department of Pharmaceutics, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India
4 Department of Pharmacology, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India
     

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Two new simple, sensitive, rapid, accurate and precise methods, namely UV spectrophotometric and RP-HPLC methods were developed for the estimation of Levosulpiride in bulk and in tablet formulation. In UV spectrophotometric method, Levosulpiride exhibited maximum absorbance at 291.5 nm with apparent molar absorptivity of 2.6031×103 L mol-1 cm-1 in 0.1 M HCl. Beer’s law was obeyed in the concentration range of 10-50 mg/ml. In RP-HPLC method, the elution was done using a mobile phase consisting of methanol and 25 mM phosphate buffer pH 3.5 (pH adjusted with phosphoric acid, 15:85 v/v) on Shimadzu HPLC C18 (4.6×150 mm) column at a flow rate of 0.8 ml/min with UV detection at 293 nm. An external standard calibration method was employed for quantization. The elution time was 5.08 minutes. Beer’s law was found to be obeyed in the concentration range of 4-24 ×g/ml. The results of proposed methods were validated statistically and by recovery studies. The % RSD values for recovery studies were found to be less than 2% for the both methods. Hence the proposed methods were successfully used to determine the drug content in bulk and in tablet formulation.

Keywords

Levosulpiride, UV Spectrophotometry, RP-HPLC, External Standard Calibration.
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  • Development of UV Spectrophotometry and RP-HPLC Methods for the Estimation of Levosulpiride in Bulk and in Tablet Formulation

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Authors

S. P. Silambarasan
Axis Clinicals Ltd, Hyderabad, Andhra Pradesh, India
K. Anandakumar
Dept. of Pharmaceutical Analysis, Adhiparasakthi College of Pharmacy, Melmaruvathur-603319, Tamilnadu, India
R. Venkatalakshmi
Department of Pharmaceutics, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India
C. Sasikala
Department of Pharmacology, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India

Abstract


Two new simple, sensitive, rapid, accurate and precise methods, namely UV spectrophotometric and RP-HPLC methods were developed for the estimation of Levosulpiride in bulk and in tablet formulation. In UV spectrophotometric method, Levosulpiride exhibited maximum absorbance at 291.5 nm with apparent molar absorptivity of 2.6031×103 L mol-1 cm-1 in 0.1 M HCl. Beer’s law was obeyed in the concentration range of 10-50 mg/ml. In RP-HPLC method, the elution was done using a mobile phase consisting of methanol and 25 mM phosphate buffer pH 3.5 (pH adjusted with phosphoric acid, 15:85 v/v) on Shimadzu HPLC C18 (4.6×150 mm) column at a flow rate of 0.8 ml/min with UV detection at 293 nm. An external standard calibration method was employed for quantization. The elution time was 5.08 minutes. Beer’s law was found to be obeyed in the concentration range of 4-24 ×g/ml. The results of proposed methods were validated statistically and by recovery studies. The % RSD values for recovery studies were found to be less than 2% for the both methods. Hence the proposed methods were successfully used to determine the drug content in bulk and in tablet formulation.

Keywords


Levosulpiride, UV Spectrophotometry, RP-HPLC, External Standard Calibration.