IJSRST207241 | Received : 10 March 2019 | Accepted : 22 March 2019 | March-April-2019 [ (6) 2 : 851-863 ]
© 2019 IJSRST | Volume 6 | Issue 2 | Print ISSN: 2395-6011 | Online ISSN: 2395-602X
doi : https://doi.org/10.32628/IJSRST218140
Themed Section: Science and Technology
851
Development and Validation of Absorption Correction UV-
Spectrophotometry Method for Simultaneous Estimation of Ranitidine HCL
and Dicyclomine Hydrochloride in Their Marketed Formulation
Bhumi Kantariya*, Dr Greeva Bhatt, Dr. Mehul Mehta, Urmi Kanatria, Ravi Dalsaniya
Lecturer Department of Pharmaceutical Chemistry, Indian Institute of Ayurvedic Pharmaceutical Sciences,
Gujarat Ayurved University, Jamnagar, Gujarat, India
ABSTRACT
A Simple, selective, precise and rapid absorption correction Spectrophotometric method has been developed
and validated as per ICH guideline for the simultaneous estimation of Ranitidine Hydrochloride and
Dicyclomine Hydrochloride in tablet dosage form. Method is base on UV Spectrophotometric for determination
of two drug, by using Methanol as a solvent and diluted the same with 0.1N NaOH, solution. In this UV
method, the two wavelength were selected, 311.4 nm and at 217 nm for RANTD and DICY, respectively. this
method was validated according to ICH guideline and Linearity range, was found to be 7.5-37.5 µg/ml and 1-5
µg/ml for RANTD and DICY, respectively. The method was successfully applied to assay drugs in tablet.
Keywords :- UV Spectrophotometric absorption correction method; Ranitidine Hydrochloride (RANTD);
Dicyclomine Hydrochloride (DICY); ICH guidelines; Validation.
I. INTRODUCTION
Ranitidine Hydrochloride N-(2-[(5-
(dimethylaminomethyl) furan-2-yl)
methylthio]ethyl)- N-methyl- 2- nitroethene- 1,1-
diamine (Figure 1) is histamine H2 receptor
antagonist. Dicyclomine Hydrochloride 2-
(diethylamino) ethyl cyclohexylcyclohexane-1-
carboxylate (Figure 2) is antiemetic, antimuscarinics
and anticholinergic agent. Combination is frequently
used in the treatment of acute ulcer.[32-37] A
literature survey revealed there are many analytical
methods reported for estimation of Ranitidine
Hydrochloride & Dicyclomine Hydrochloride in
individuals & in combination with other drugs in
bulk and pharmaceutical dosage forms.[45-52] We
have developed and validate new specific, very simple,
accurate, precise spectrophotometry for estimation of
marketed drug formulations.
O
S
H
N
H
N
CHNO
2
H
3
C
N
H
3
C
CH
3
Figure 1 : Ranitidine Hydrochloride
O
O
N
H
3
C
H
3
C
HCl