VALIDATED HPLC AND HPTLC METHOD FOR SIMULTANEOUS QUANTITATION OF ONDANSETRON HYDROCHLORIDE AND PARACETAMOL IN BULK DRUG AND FORMULATION

Authors

  • L. D. KHATAL College of Pharmacy, Kolhapur, Near Chitranagri, Kolhapur, Maharashtra,India.
  • H. N. MORE College of Pharmacy, Kolhapur, Near Chitranagri, Kolhapur, Maharashtra,India.
  • A. N. JADHAV SAI Life Sciences Limited Pune, India
  • B. S. KUCHEKAR Maharashtra Institute Of Pharmacy, MIT Campus, Pune, India.
  • S. R. DHANESHWAR Department of Pharmaceutical Chemistry, RAKMHSU College of Pharm. Sciences, P.O. Box 11172, Ras Al Khaimah, UAE
  • A. R.POLAWAR AISSMS College of Pharmacy, Kennedy road, Pune, India.

Keywords:

Ondansetron Hydrochloride; Paracetamol; HPLC; HPTLC; Validation

Abstract

Purpose: To develop and validate the HPLC and HPTLC methods for the simultaneous determination of Ondansetron
Hydrochloride (OND) and Paracetamol (PARA) in binary mixture. Methods: The first method was based on HPTLC
separation of the two drugs followed by densitometric measurements of their spots at 286 nm. The separation was carried
out on Merck HPTLC aluminium sheets of silica gel 60 F254 using toluene: methanol: acetone (6: 2: 2.5, v/v/v) as the mobile
phase. The second method was based on HPLC separation of the two drugs on the reverse phase PerfectSil-100 ODS-3–C18
(250 mm × 4.6 mm, 5.0 ?) from MZ-Analysetechnik GmbH, Germany column and acetonitrile : 0.05 M Ammonium acetate
buffer (pH = 6 adjusted with glacial acetic acid) in a ratio of 40:60 as mobile phase. The flow rate was 1 ml/min. Results:
The linear regression data was used for the regression line in the range of 40–200 ng/spot for OND and 2500-12500 ng/spot
for PARA by HPTLC. Quantitation by HPLC was achieved with UV detection at 286 nm based on peak area with linear
calibration curves at concentration ranges 2-10 and 125-625 ?g/ml for OND and PARA, respectively. Conclusion: Both
methods have been applied to pharmaceutical formulation without interference of excipients of formulation. Both methods
were validated in terms of precision, robustness, recovery, limit of detection and quantitation.

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Published

2014-10-05
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How to Cite

L. D. KHATAL, H. N. MORE, A. N. JADHAV, B. S. KUCHEKAR, S. R. DHANESHWAR, and A. R.POLAWAR. “VALIDATED HPLC AND HPTLC METHOD FOR SIMULTANEOUS QUANTITATION OF ONDANSETRON HYDROCHLORIDE AND PARACETAMOL IN BULK DRUG AND FORMULATION”. International Journal of Pharmaceutics and Drug Analysis, vol. 2, no. 10, Oct. 2014, pp. 785-94, https://ijpda.com/index.php/journal/article/view/118.

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