Validation of four different spectrophotometric methods for simultaneous determination of Domperidone and Ranitidine in bulk and pharmaceutical formulation.
Four simple, specific, accurate and precise spectrophotometric methods were developed and validated for simultaneous determination of Domperidone (DP) and Ranitidine Hydrochloride (RT) in bulk powder and pharmaceutical formulation. The first method was simultaneous ratio subtraction (SRS), the second was ratio subtraction (RS) coupled with zero order spectrophotometry (D(0)), the third was first derivative of the ratio spectra ((1)DD) and the fourth method was mean centering of ratio spectra (MCR). The calibration curve is linear over the concentration range of 0.5-5 and 1-45 μg mL(-1) for DP and RT, respectively. The proposed spectrophotometric methods can analyze both drugs without any prior separation steps. The selectivity of the adopted methods was tested by analyzing synthetic mixtures of the investigated drugs, also in their pharmaceutical formulation. The suggested methods were validated according to International Conference of Harmonization (ICH) guidelines and the results revealed that; they were precise and reproducible. All the obtained results were statistically compared with those of the reported method, where there was no significant difference.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Organization of African Unity Street, Abassia, Cairo 11566, Egypt.
Maha F
MF
Abdel-Ghany
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Organization of African Unity Street, Abassia, Cairo 11566, Egypt.
Omar
O
Abdel-Aziz
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Organization of African Unity Street, Abassia, Cairo 11566, Egypt. Electronic address: yomna_yousry@yahoo.com.
Yomna Y
YY
Mohammed
D000704:Analysis of Variance; D002626:Chemistry, Pharmaceutical; D004294:Domperidone / Q000032:analysis* / Q000737:chemistry; D057230:Limit of Detection; D011208:Powders; D011899:Ranitidine / Q000032:analysis* / Q000737:chemistry; D012015:Reference Standards; D012044:Regression Analysis; D013053:Spectrophotometry / Q000379:methods*
D011208:Powders; D004294:Domperidone; D011899:Ranitidine
Derivative ratio; Domperidone; Mean centering; Ranitidine HCl; Ratio subtraction; Simultaneous ratio subtraction