RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METRONIDAZOLE, CLINDAMYCIN PHOSPHATE AND CLOTRIMAZOLE IN COMBINED PHARMACEUTICAL DOSAGE FORMS

Abstract

A simple, efficient and reproducible Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method
for simultaneous determination of metronidazole, clindamycin phosphate and clotrimazole in combined pharmaceutical dosage
forms has been developed. The separation was carried out on Hypersil BDS C8 (250 × 4.6mn; 5μm) column using buffer, 13.6g
of potassium dihydrogen ortho phosphoric acid in 1000ml of water (adjusted to pH 2.4 with ortho phosphoric acid) : acetonitrile
70:30 v/v as eluent. The flow rate was 2.3 ml/min and effluent was detected at 210 nm. The retention times of metronidazole,
clindamycin phosphate and clotrimazole were 4.862 min, 5.712 min and 26.01min respectively. The percentage recovery was
within the range between 99.38% and 100.31% for metronidazole, 98.76% and 100.65% for clindamycin phosphate, 99.98% and
99.63% for clotrimazole. The linear ranges were found to be 80-150μg/ml (r2 = 0.9983) for metronidazole, 80-150μg/ml (r2 =
0.9993) for clindamycin phosphate and 80-150μg/ml (r2 = 0.9984) for clotrimazole. The percentage relative standard deviation for
accuracy and precision was found to be less than 2%. Hence, the method could be successfully applied for routine analysis of
metronidazole, clindamycin phosphate and clotrimazole in the combined pharmaceutical dosage form.