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Table 11 Mass balance and peak purity study of DOX

From: A stability-indicating HPLC method for estimation of doxylamine succinate in tablets and characterization of its major alkaline stress degradation product

Stress conditions

% Degradation*

Purity angle

Purity threshold

% Assay

Mass balance

RT of degradant (min)

Acid

9.75

0.317

1.082

89.51

99.26

2.018, 3.917

Alkaline

15.15

0.198

0.501

83.83

98.98

1.422, 3.287

Neutral

5.8

0.227

0.691

93.31

99.11

2.584

Oxidative

12.25

0.358

0.828

87.74

99.99

3.496, 12.311

Photolytic

0

0.496

0.956

98.62

98.62

Thermal

0

0.101

0.472

99.01

99.01

  1. *Average of three determinations