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VOL. 11, ISSUE 3 (2026)
Development and validation of a stability-indicating RP-UPLC method for the estimation of loxapine in bulk drug and pharmaceutical dosage form
Authors
Narasimha Rao B V, Prasada Rao M, Gayathri Devi K, Udaya Krishna Veni A, Azuma Shaik
Abstract
A rapid and reliable ultra-performance liquid chromatographic (UPLC)
method was developed and validated for the quantitative estimation of Loxapine
in bulk drug and pharmaceutical dosage form. The method was developed using a
Waters ACQUITY UPLC H-Class system equipped with a photodiode array detector.
Chromatographic separation was achieved on an ACQUITY BEH C18 column (2.1 × 50
mm, 1.7 µm) using acetonitrile and phosphate buffer (pH 3.0) containing 0.1%
triethylamine in a 65:35 (v/v) ratio as the mobile phase. The flow rate was 0.3
mL/min, detection was performed at 254 nm, injection volume was 2 µL, and the
total run time was 8 min. Loxapine showed a retention time of 3.898 min with
4596 theoretical plates and a tailing factor of 0.87. The method was validated
for system suitability, specificity, sensitivity, linearity, precision,
accuracy, ruggedness, robustness, and forced degradation. Linearity was
established over 2.5–15 µg/mL with r² = 0.99978. The LOD and LOQ were 0.257 and
0.777 µg/mL, respectively. Accuracy studies showed recoveries of 98.50–99.06%
with %RSD values below 2%. System precision and method precision showed %RSD
values of 0.71% and 0.70%, respectively. The method demonstrated acceptable
ruggedness and robustness. Forced degradation showed maximum degradation under
acid stress (4.45%), followed by alkali (3.55%) and oxidative stress (3.20%),
while neutral hydrolysis, thermal, and photolytic conditions produced
comparatively lower degradation. The assay was 98.92% for the bulk drug and
99.99% of label claim for the marketed capsule formulation. The developed
method was therefore found to be suitable for routine quantitative analysis of
Loxapine in bulk drug and pharmaceutical dosage form.
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Pages:59-62
How to cite this article:
Narasimha Rao B V, Prasada Rao M, Gayathri Devi K, Udaya Krishna Veni A, Azuma Shaik "Development and validation of a stability-indicating RP-UPLC method for the estimation of loxapine in bulk drug and pharmaceutical dosage form". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 11, Issue 3, 2026, Pages 59-62
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